Evidence Record
evt_NCT03094169_v10_v11_d3f5f1846526
NCT03094169 · AVID100 in Advanced Epithelial Carcinomas
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: Low Category
Results Reconciliation
Versions
v10 to v11
Timing
Post Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 10 to version 11 for NCT03094169.
- The JSON Patch for this comparison has hash 399464a46575754e61db659a07bb6f3598223d97b828fc8938fe562956cadcb2.
- The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.
- The deterministic triage label was low; before timing adjustment it was low.
- 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.
- The timing context for the from-version record was post_recruitment.
- The changed JSON Pointer paths were: /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /hasResults, /resultsSection, /annotationSection, /documentSection.
- An outcome path changed between versions 10 and 11 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 source document explains this registry amendment, and does it change interpretation of the trial record?
Citation
TrialDiff Evidence Record evt_NCT03094169_v10_v11_d3f5f1846526. ClinicalTrials.gov NCT03094169, versions 10-11. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit
/protocolSection/outcomesModule/primaryOutcomes/1/measure
/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame
/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
/hasResults
/resultsSection
/annotationSection
/documentSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
No deterministic rules recorded.
Provenance
- Package generation
v0.1.3(active)- Supersedes
- evt_NCT03094169_v10_v11_bee53ee2882b
- Patch hash
399464a46575754e61db659a07bb6f3598223d97b828fc8938fe562956cadcb2- Canonical hash
f0d33e359a1ab438d5444ec2108308c797809d704c0f232f6732dd92b48709f3- Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621- From snapshot
20394da165995825ccc98ed504f1c6708647daf8d61915bc885347ac368fbad3- To snapshot
c1651ac90d15af75bb072872aa2e524dc6163c44941e3c8c32eb1a5376c6e0aa- Patch source
- ctgov_internal_history
- Generated at
- 2026-08-03T06:46:43.000Z
- Source URL
- Registry payload
Canonical JSON Preview
Stored payload{
"changed_paths": [
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
"/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"/hasResults",
"/resultsSection",
"/annotationSection",
"/documentSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT03094169_v10_v11_d3f5f1846526. ClinicalTrials.gov NCT03094169, versions 10-11. 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 10 to version 11 for NCT03094169.",
"The JSON Patch for this comparison has hash 399464a46575754e61db659a07bb6f3598223d97b828fc8938fe562956cadcb2.",
"The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
"The deterministic triage label was low; before timing adjustment it was low.",
"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.",
"The timing context for the from-version record was post_recruitment.",
"The changed JSON Pointer paths were: /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /hasResults, /resultsSection, /annotationSection, /documentSection.",
"An outcome path changed between versions 10 and 11 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"results_reconciliation"
],
"category": "results_reconciliation",
"deterministic_rules": [],
"event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
"event_classes": [
"outcome_edit_cooccurs_with_results_posting"
],
"rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
"severity": "low",
"severity_pre_timing": "low",
"timing_context": "post_recruitment",
"triage_label": "low",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit",
"/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT03094169_v10_v11_d3f5f1846526",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2021-09-10"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2021-10-07"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2021-09-10"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Phase 1a: Determine Safety and Tolerability of AVID100"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "Overall study timeframe"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"value": "Phase 2a: Evaluation of the Preliminary Antineoplastic Effects of AVID100"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
"value": "Overall Study"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit",
"value": {
"resetReasons": [
"The measure does not appear to include sufficient information to understand how outcomes are measured and reported.",
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "Not Completed"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"armsReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
},
"eventGroups": [
{
"deathsNumAffected": 1,
"deathsNumAtRisk": 24,
"description": "<p>Minimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>",
"id": "EG000",
"otherNumAffected": 23,
"otherNumAtRisk": 24,
"seriousNumAffected": 8,
"seriousNumAtRisk": 24,
"title": "Dose Escalation"
},
{
"deathsNumAffected": 2,
"deathsNumAtRisk": 6,
"description": "<p>Addition of up to 15 patients in each of 2 subpopulations of patients with triple negative breast cancer (30 total).\nOne group of 15 patients will have 3+ EGFR over-expression.\nThe second group will have 2+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>",
"id": "EG001",
"otherNumAffected": 6,
"otherNumAtRisk": 6,
"seriousNumAffected": 3,
"seriousNumAtRisk": 6,
"title": "Phase 2a Triple Negative Breast Cancer"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 15,
"description": "<p>Addition of 15 patients with squamous head and neck carcinoma.\nPatients will have 3+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>",
"id": "EG002",
"otherNumAffected": 15,
"otherNumAtRisk": 15,
"seriousNumAffected": 9,
"seriousNumAtRisk": 15,
"title": "Phase 2a Head and Neck Carcinoma"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 3,
"description": "<p>Addition of 15 patients with squamous histology non-small cell lung carcinoma.\nPatients will have 3+ EGFR over-expression</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>",
"id": "EG003",
"otherNumAffected": 3,
"otherNumAtRisk": 3,
"seriousNumAffected": 1,
"seriousNumAtRisk": 3,
"title": "Phase 2a Non-Small Cell Lung Carcinoma"
}
],
"frequencyThreshold": "5",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 11,
"numAtRisk": 24,
"numEvents": 11
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 6,
"numEvents": 2
},
{
"groupId": "EG002",
"numAffected": 6,
"numAtRisk": 15,
"numEvents": 6
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Nausea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 24,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 15,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Viral Upper Respiratory Tract Infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 24,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 6,
"numEvents": 2
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 15,
"numEvents": 3
},
{
"groupId": "EG003",
"numAffected": 1,
"numAtRisk": 3,
"numEvents": 1
}
],
"term": "Dyspnoea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 24,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 15,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Dry Eye"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 24,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 15,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Dehydration"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 24,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 15,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Cystitis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 24,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 15,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Conjunctivitis Allergic"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 24,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 15,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Blood Bilirubin Increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 24,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 15,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Tumour Pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 24,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 15,
"numEvents": 2
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Lymphocyte Count Decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 24,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 15,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Keratitis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 24,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 15,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 2,
"numAtRisk": 3,
"numEvents": 2
}
],
"term": "Dry Skin"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 24,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 4,
"numAtRisk": 15,
"numEvents": 4
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Constipation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 24,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 15,
"numEvents": 3
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Blood Alkaline Phosphate Increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 24,
"numEvents": 4
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 15,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Nasal Congestion"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 24,
"numEvents": 4
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 15,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Lipase Increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 24,
"numEvents": 4
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 15,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Headache"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 22.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 24,
"numEvents": 4
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 6,
"numEvents": 2
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 15,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "Diarrhoea"
},
{
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