Evidence Record
evt_NCT01818063_v14_v15_1d0b17c2f61b
NCT01818063 · Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer
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
Timeline Minor Adjustment
Versions
v14 to v15
Timing
Late Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 14 to version 15 for NCT01818063.
- The JSON Patch for this comparison has hash 3b34ee57f0bf5eb3ee1858404e8a7f98410235d62b218fd80457276481690f8f.
- 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 late_recruitment.
- The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/referencesModule/seeAlsoLinks/0, /hasResults, /resultsSection.
- The timeline value moved by 275 days.
- An outcome path changed between versions 14 and 15 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_NCT01818063_v14_v15_1d0b17c2f61b. ClinicalTrials.gov NCT01818063, versions 14-15. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/secondaryOutcomes/0/measure
/protocolSection/outcomesModule/secondaryOutcomes/1/measure
/protocolSection/referencesModule/seeAlsoLinks/0
/hasResults
/resultsSection
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_NCT01818063_v14_v15_1ec2c63cf2e6
- Patch hash
3b34ee57f0bf5eb3ee1858404e8a7f98410235d62b218fd80457276481690f8f- Canonical hash
a7327845ef02be9454efc0e6192b261bd5ca88c5dd05ff970c966169da0f3494- Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621- From snapshot
e7c2f5cfa87463e9014601f04d4fe591d3a3826c2ccadce96528761a80e0922d- To snapshot
5533a5710a87296df798572e29262c3d74af0c24441d1907929efa0bf7a027af- 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/statusVerifiedDate",
"/protocolSection/statusModule/completionDateStruct/date",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/statusModule/resultsFirstSubmitQcDate",
"/protocolSection/statusModule/resultsFirstPostDateStruct",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/referencesModule/seeAlsoLinks/0",
"/hasResults",
"/resultsSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT01818063_v14_v15_1d0b17c2f61b. ClinicalTrials.gov NCT01818063, versions 14-15. 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 14 to version 15 for NCT01818063.",
"The JSON Patch for this comparison has hash 3b34ee57f0bf5eb3ee1858404e8a7f98410235d62b218fd80457276481690f8f.",
"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 late_recruitment.",
"The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/referencesModule/seeAlsoLinks/0, /hasResults, /resultsSection.",
"The timeline value moved by 275 days.",
"An outcome path changed between versions 14 and 15 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"timeline_minor_adjustment",
"results_reconciliation"
],
"category": "timeline_minor_adjustment",
"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": "late_recruitment",
"triage_label": "low",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "timeline_minor_adjustment",
"date_struct": "completionDateStruct",
"delta_days": 275,
"direction": "earlier",
"new_precision": "month",
"new_type": "ESTIMATED",
"new_value": "2018-04",
"old_precision": "month",
"old_type": "ESTIMATED",
"old_value": "2019-01",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"severity": "low",
"signal": "timeline_earlier_adjustment"
},
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT01818063_v14_v15_1d0b17c2f61b",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2017-12"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2018-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2017-12-14"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2018-01-16"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2017-12-14"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2017-12-14"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2018-01-16",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Count of Participants That Achieve Pathologic Complete Response (PCR)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Overall Clinical Response"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Relapse Free Survival"
},
{
"op": "remove",
"path": "/protocolSection/referencesModule/seeAlsoLinks/0"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"eventGroups": [
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 5,
"description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>",
"id": "EG000",
"otherNumAffected": 3,
"otherNumAtRisk": 5,
"seriousNumAffected": 1,
"seriousNumAtRisk": 5,
"title": "Arm 1 (Paclitaxel, Carboplatin)"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 4,
"description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>",
"id": "EG001",
"otherNumAffected": 1,
"otherNumAtRisk": 4,
"seriousNumAffected": 0,
"seriousNumAtRisk": 4,
"title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)"
}
],
"frequencyThreshold": "5",
"otherEvents": [
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Alopecia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 7
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Alkaline phosphatase Increased"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "ALT Increase"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Anemia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Anxiety"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 7
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Bone Pain"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 7
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Burn"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Constipation"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Cough"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Dehydration"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Diarrhea"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Diverticulitis"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Dizziness"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Dyspnea"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Fall"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Fatigue"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 2
}
],
"term": "Flu like symptoms"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Head Injury"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Hot flashes"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Hyperglycemia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Hypoglycemia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Infection UTI"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 2
}
],
"term": "Insomnia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Laryngeal Inflammation"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 2
}
],
"term": "Mucositis"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 2
}
],
"term": "Nausea"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Neuropathy"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Night Sweats"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Pain"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Paresthesia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Platelet Count decreased"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
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"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Psychiatric Disorders, mood"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"stats": [
{
"groupId": "EG000",
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"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Rash Acneiform"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Rash Maculopapular"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 4,
"numEvents": 1
}
],
"term": "Runny nose"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Scalp pain"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Sciatica"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Scratch"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Urinary Urgency"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Voice alteration"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Vomiting"
}
],
"seriousEvents": [
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 4,
"numEvents": 0
}
],
"term": "Viral Meningitis"
}
]
},
"baselineCharacteristicsModule": {
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "4"
},
{
"groupId": "BG002",
"value": "9"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>",
"id": "BG000",
"title": "Arm 1 (Paclitaxel, Carboplatin)"
},
{
"description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>",
"id": "BG001",
"title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)"
},
{
"description": "Total of all reporting groups",
"id": "BG002",
"title": "Total"
}
],
"measures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"title": "<=18 years"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "3"
},
{
"groupId": "BG001",
"value": "4"
},
{
"groupId": "BG002",
"value": "7"
}
],
"title": "Between 18 and 65 years"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "2"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "2"
}
],
"title": ">=65 years"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Age, Categorical",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "4"
},
{
"groupId": "BG002",
"value": "9"
}
],
"title": "Female"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"title": "Male"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Sex: Female, Male",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "1"
}
],
"title": "Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "3"
},
{
"groupId": "BG002",
"value": "8"
}
],
"title": "Not Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"title": "Unknown or Not Reported"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Ethnicity (NIH/OMB)",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"title": "American Indian or Alaska Native"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"title": "Asian"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"title": "Native Hawaiian or Other Pacific Islander"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "2"
},
{
"groupId": "BG002",
"value": "3"
}
],
"title": "Black or African American"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "4"
},
{
"groupId": "BG001",
"value": "2"
},
{
"groupId": "BG002",
"value": "6"
}
],
"title": "White"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"title": "More than one race"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"title": "Unknown or Not Reported"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Race (NIH/OMB)",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "4"
},
{
"groupId": "BG002",
"value": "9"
}
]
}
],
"title": "United States"
}
],
"paramType": "NUMBER",
"title": "Region of Enrollment",
"unitOfMeasure": "participants"
}
]
},
"moreInfoModule": {
"certainAgreement": {
"piSponsorEmployee": true
},
"pointOfContact": {
"email": "edith.mitchell@jefferson.edu",
"organization": "Sidney Kimmel Cancer Center at Thomas Jefferson University",
"phone": "215-955-8874",
"title": "Dr. Edith Mitchell"
}
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "3"
},
{
"groupId": "OG001",
"value": "3"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "5"
},
{
"groupId": "OG001",
"value": "4"
}
],
"units": "Participants"
}
],
"description": "PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.",
"groups": [
{
"description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>",
"id": "OG000",
"title": "Arm 1 (Paclitaxel, Carboplatin)"
},
{
"description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>",
"id": "OG001",
"title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"reportingStatus": "POSTED",
"timeFrame": "At the time of surgery",
"title": "Count of Participants That Achieve Pathologic Complete Response (PCR)",
"type": "PRIMARY",
"unitOfMeasure": "Participants"
},
{
"anticipatedPostingDate": "2019-04",
"denomUnitsSelected": "Participants",
"description": "The proportion of subjects with each category of overall clinical response will be summarized by presence of baseline measureable disease (i.e., complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], unable to evaluate [UE], neurogenerative disease [ND]).\nBeta will be used as priors for combination regimens in calculating the posterior distribution of the PCR for each respective treatment group.\nAmong subjects with measurable disease, a 95% credible region will be calculated for the odds ratio for each treatment combination relative to each other.",
"reportingStatus": "NOT_POSTED",
"timeFrame": "Up to 3 years",
"title": "Overall Clinical Response",
"type": "SECONDARY"
},
{
"anticipatedPostingDate": "2019-04",
"denomUnitsSelected": "Participants",
"description": "Analyzed using Kaplan-Meier methods, stratified by study group, and the log rank test will be completed.",
"reportingStatus": "NOT_POSTED",
"timeFrame": "Up to 3 years",
"title": "Relapse Free Survival",
"type": "SECONDARY"
}
]
},
"participantFlowModule": {
"groups": [
{
"description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>",
"id": "FG000",
"title": "Arm 1 (Paclitaxel, Carboplatin)"
},
{
"description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>",
"id": "FG001",
"title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)"
}
],
"periods": [
{
"milestones": [
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "5"
},
{
"groupId": "FG001",
"numSubjects": "4"
}
],
"type": "STARTED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "5"
},
{
"groupId": "FG001",
"numSubjects": "4"
}
],
"type": "COMPLETED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
],
"type": "NOT COMPLETED"
}
],
"title": "Overall Study"
}
]
}
}
}
],
"provenance": {
"from_snapshot_hash": "e7c2f5cfa87463e9014601f04d4fe591d3a3826c2ccadce96528761a80e0922d",
"materiality_event_hash": "7b79f53742fb70751a912a86cb571bc01b05016a8b80f42c8e060f4560e60c24",
"patch_hash": "3b34ee57f0bf5eb3ee1858404e8a7f98410235d62b218fd80457276481690f8f",
"patch_raw_hash": "997aceb9617118bbd9a4d64750d16df2e2cef981e3c4e6b968166ac8443a6c1f",
"patch_source": "ctgov_internal_history",
"patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT01818063/history/14?patchToVersion=15",
"to_snapshot_hash": "5533a5710a87296df798572e29262c3d74af0c24441d1907929efa0bf7a027af"
},
"review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
"schema": "trialdiff.evidence_record",
"trial": {
"clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT01818063",
"nct_id": "NCT01818063"
},
"versions": {
"from_version": 14,
"submitted_date": "2017-12-14",
"to_version": 15
}
}