Evidence Record
evt_NCT03025035_v19_v20_511188c2faf6
NCT03025035 · Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer
Superseded Evidence Record
This page preserves the immutable v0.1.2 record. Its current successor is evt_NCT03025035_v19_v20_c37643ec200b.
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. This page states what the registry evidence supports and what it does not support.
Triage severity
Triage: High Category
Enrollment Change
Versions
v19 to v20
Timing
Late Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 19 to version 20 for NCT03025035.
- The JSON Patch for this comparison has hash 9d118dae2c36afd922674081d56e81b0e99e942c214d9481579211079cad405f.
- The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.
- The deterministic triage label was high; before timing adjustment it was high.
- The triage label is uncalibrated metadata, not a validated review-priority finding.
- The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.
- A registry field under enrollment changed between ClinicalTrials.gov versions 19 and 20.
- The timing context for the from-version record was late_recruitment.
- The deterministic rules that fired were: enrollment_count_change, enrollment_type_change.
- The changed JSON Pointer paths were: /protocolSection/identificationModule/briefTitle, /protocolSection/identificationModule/officialTitle, /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/oversightModule/isUsExport, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /hasResults, /resultsSection, /annotationSection, /documentSection.
- The enrollment count changed by at least 20 percent.
- An outcome path changed between versions 19 and 20 in a patch that also carried a hasResults or resultsSection co-occurrence signal.
Claims Not Supported
- That the amendment was scientifically unjustified.
- That the change constitutes misconduct or wrongdoing.
- That sponsor intent can be inferred from this registry change.
- That the change caused or altered the trial's results.
- That the change was or was not disclosed in a manuscript.
- That TrialDiff determines regulatory compliance or non-compliance.
- That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.
- That event-class membership is a validated global review-priority ranking.
Neutral Review Question
What explains the enrollment change, and does the change affect interpretation of trial feasibility or power?
Citation
TrialDiff Evidence Record evt_NCT03025035_v19_v20_511188c2faf6. ClinicalTrials.gov NCT03025035, versions 19-20. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/identificationModule/briefTitle
/protocolSection/identificationModule/officialTitle
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/oversightModule/isUsExport
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/designModule/enrollmentInfo/type
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/secondaryOutcomes/0/measure
/protocolSection/outcomesModule/secondaryOutcomes/1/measure
/protocolSection/outcomesModule/secondaryOutcomes/2/measure
/protocolSection/outcomesModule/secondaryOutcomes/3/measure
/hasResults
/resultsSection
/annotationSection
/documentSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
enrollment_count_changeenrollment_type_change Provenance
- Package generation
v0.1.2- Succeeded by
- evt_NCT03025035_v19_v20_c37643ec200b
- Patch hash
9d118dae2c36afd922674081d56e81b0e99e942c214d9481579211079cad405f- Canonical hash
4eed1601579954b71f1b38ee42548b3bdba30761586c8e68773974fd2387d50d- Rule set hash
318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86- From snapshot
deb474995db93f9edf694035d8307bf289c37ea46805fdc8a7fc05867a1ecb91- To snapshot
17c518b5db5b4c88066f59a66a3987882985e29795e31da500724064e08e2fd9- Patch source
- ctgov_internal_history
- Generated at
- 2026-07-31T00:42:12.000Z
- Source URL
- Registry payload
Canonical JSON Preview
Stored payload{
"changed_paths": [
"/protocolSection/identificationModule/briefTitle",
"/protocolSection/identificationModule/officialTitle",
"/protocolSection/statusModule/statusVerifiedDate",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/oversightModule/isUsExport",
"/protocolSection/designModule/enrollmentInfo/count",
"/protocolSection/designModule/enrollmentInfo/type",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"/hasResults",
"/resultsSection",
"/annotationSection",
"/documentSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT03025035_v19_v20_511188c2faf6. ClinicalTrials.gov NCT03025035, versions 19-20. Evidence version 1.",
"claims_not_supported": [
"That the amendment was scientifically unjustified.",
"That the change constitutes misconduct or wrongdoing.",
"That sponsor intent can be inferred from this registry change.",
"That the change caused or altered the trial's results.",
"That the change was or was not disclosed in a manuscript.",
"That TrialDiff determines regulatory compliance or non-compliance.",
"That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.",
"That event-class membership is a validated global review-priority ranking."
],
"claims_supported": [
"TrialDiff compared ClinicalTrials.gov record version 19 to version 20 for NCT03025035.",
"The JSON Patch for this comparison has hash 9d118dae2c36afd922674081d56e81b0e99e942c214d9481579211079cad405f.",
"The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
"The deterministic triage label was high; before timing adjustment it was high.",
"The triage label is uncalibrated metadata, not a validated review-priority finding.",
"The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.",
"A registry field under enrollment changed between ClinicalTrials.gov versions 19 and 20.",
"The timing context for the from-version record was late_recruitment.",
"The deterministic rules that fired were: enrollment_count_change, enrollment_type_change.",
"The changed JSON Pointer paths were: /protocolSection/identificationModule/briefTitle, /protocolSection/identificationModule/officialTitle, /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/oversightModule/isUsExport, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /hasResults, /resultsSection, /annotationSection, /documentSection.",
"The enrollment count changed by at least 20 percent.",
"An outcome path changed between versions 19 and 20 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"enrollment_change",
"results_reconciliation"
],
"category": "enrollment_change",
"deterministic_rules": [
"enrollment_count_change",
"enrollment_type_change"
],
"event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
"event_classes": [
"outcome_edit_cooccurs_with_results_posting"
],
"rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
"severity": "high",
"severity_pre_timing": "high",
"timing_context": "late_recruitment",
"triage_label": "high",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "enrollment_change",
"new_value": 14,
"old_value": 20,
"path": "/protocolSection/designModule/enrollmentInfo/count",
"pct_change": 0.3,
"severity": "high",
"signal": "enrollment_count_change_ge_20pct"
},
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/3/measure"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT03025035_v19_v20_511188c2faf6",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/identificationModule/briefTitle",
"value": "Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer"
},
{
"op": "replace",
"path": "/protocolSection/identificationModule/officialTitle",
"value": "Open Label, Phase II Pilot Study of Immune Checkpoint Inhibition With Pembrolizumab in Combination With PARP Inhibition With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancers"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2025-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2025-04-29"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2025-05-09"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2025-04-29"
},
{
"op": "remove",
"path": "/protocolSection/oversightModule/isUsExport"
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 14
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Overall Response Rate (ORR) Per RECIST1.1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Progression Free Survival (PFS), Per RECIST 1.1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Overall Survival (OS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Clinical Benefit Rate (CBR = CR+PR+SD) Per RECIST 1.1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Duration of Response (DOR) for Complete Response (CR) and Partial Response (PR) Per RECIST 1.1"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"allCauseMortalityReviewUnit": {
"resetReasons": [
"Information in other parts of the record suggests that adverse events were collected that are not reported here."
]
},
"eventGroups": [
{
"deathsNumAffected": 1,
"deathsNumAtRisk": 11,
"description": "<p>This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy.</p><p>Pembrolizumab: Pembrolizumab IV solution administered on Day 1 of each 3-week cycle</p><p>Olaparib: Olaparib administered orally twice a day</p>",
"id": "EG000",
"otherNumAffected": 11,
"otherNumAtRisk": 11,
"seriousNumAffected": 0,
"seriousNumAtRisk": 11,
"title": "Pembrolizumab + Olaparib"
}
],
"frequencyThreshold": "0",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 11,
"numEvents": 14
}
],
"term": "Anemia Hemoglobin"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 11,
"numEvents": 2
}
],
"term": "Anorexia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Anorexia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Anxiety"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 11,
"numEvents": 3
}
],
"term": "Back Pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Bloating"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Blood Bilirubin Increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Concentration Impairment"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 11,
"numEvents": 3
}
],
"term": "Constipation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Cough"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Creatinine increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 11,
"numEvents": 3
}
],
"term": "Diarrhea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 11,
"numEvents": 2
}
],
"term": "Dizziness"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 11,
"numEvents": 2
}
],
"term": "Dysgeusia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Dysgeusia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 11,
"numEvents": 2
}
],
"term": "Edema Limbs"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Eye disorders - Other"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Eye pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Eyelid Function Disorder"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 11,
"numEvents": 2
}
],
"term": "Fall"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 11,
"numEvents": 4
}
],
"term": "Fatigue"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Flank Pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Gastroesophagael Reflux"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 11,
"numEvents": 4
}
],
"term": "Headache"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Hypercalcemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Endocrine disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 11,
"numEvents": 2
}
],
"term": "Hyperthyroidism"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Insomnia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Joint Range of Motion Decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Malaise"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Mucositis Oral"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Myalgia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 11,
"numEvents": 8
}
],
"term": "Nausea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 2
}
],
"term": "Non-Cardiac Chest Pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Oral Pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Other- Pain at Biopsy Site"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Ear and labyrinth disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Other- Tinnitus"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Other- Muscle Cramps"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 11,
"numEvents": 2
}
],
"term": "Pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Pain in Extremity"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Palpitations"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Paresthesia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 11,
"numEvents": 1
}
],
"term": "Peripheral Sensory Neuropathy"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"stats": [
{
"groupId": "EG000",
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