Evidence Record
evt_NCT01275677_v907_v908_bdf3fe64c69e
NCT01275677 · Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive 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: High Category
Enrollment Change
Versions
v907 to v908
Timing
Late Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 907 to version 908 for NCT01275677.
- The JSON Patch for this comparison has hash 4dd658fc2e7e8fc67e96ff7044f294c47bb630e0c1a342948254ec4b9fdd7731.
- The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.
- 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 907 and 908.
- The timing context for the from-version record was late_recruitment.
- The deterministic rules that fired were: enrollment_count_change.
- The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/descriptionModule/briefSummary, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/6/measure, /protocolSection/outcomesModule/secondaryOutcomes/7/measure, /annotationSection, /documentSection/largeDocumentModule/largeDocs/0/date, /hasResults, /resultsSection.
- An outcome path changed between versions 907 and 908 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_NCT01275677_v907_v908_bdf3fe64c69e. ClinicalTrials.gov NCT01275677, versions 907-908. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/descriptionModule/briefSummary
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/secondaryOutcomes/0/measure
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/0/description
/protocolSection/outcomesModule/secondaryOutcomes/1/measure
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/1/description
/protocolSection/outcomesModule/secondaryOutcomes/2/measure
/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/2/description
/protocolSection/outcomesModule/secondaryOutcomes/3/measure
/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/3/description
/protocolSection/outcomesModule/secondaryOutcomes/4/measure
/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/4/description
/protocolSection/outcomesModule/secondaryOutcomes/5/measure
/protocolSection/outcomesModule/secondaryOutcomes/5/description
/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/6/measure
/protocolSection/outcomesModule/secondaryOutcomes/7/measure
/annotationSection
/documentSection/largeDocumentModule/largeDocs/0/date
/hasResults
/resultsSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
enrollment_count_change Provenance
- Package generation
v0.1.3(active)- Supersedes
- evt_NCT01275677_v907_v908_46a598ee1845
- Patch hash
4dd658fc2e7e8fc67e96ff7044f294c47bb630e0c1a342948254ec4b9fdd7731- Canonical hash
2cd65b6bbb60ff2e48637317ab144a9ba08a3d86087430beb0190c5430609ce8- Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621- From snapshot
a219254bd24d2442d0fbde38e9baa02b0cc447da2708e379735391cca0ebe135- To snapshot
04e26bee4924910dfc251a2c33982177ff6a9acfcff9763da2c23a04c00bd349- 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/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/statusModule/resultsFirstSubmitQcDate",
"/protocolSection/statusModule/resultsFirstPostDateStruct",
"/protocolSection/descriptionModule/briefSummary",
"/protocolSection/designModule/enrollmentInfo/count",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
"/annotationSection",
"/documentSection/largeDocumentModule/largeDocs/0/date",
"/hasResults",
"/resultsSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT01275677_v907_v908_bdf3fe64c69e. ClinicalTrials.gov NCT01275677, versions 907-908. 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 907 to version 908 for NCT01275677.",
"The JSON Patch for this comparison has hash 4dd658fc2e7e8fc67e96ff7044f294c47bb630e0c1a342948254ec4b9fdd7731.",
"The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
"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 907 and 908.",
"The timing context for the from-version record was late_recruitment.",
"The deterministic rules that fired were: enrollment_count_change.",
"The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/descriptionModule/briefSummary, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/6/measure, /protocolSection/outcomesModule/secondaryOutcomes/7/measure, /annotationSection, /documentSection/largeDocumentModule/largeDocs/0/date, /hasResults, /resultsSection.",
"An outcome path changed between versions 907 and 908 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"
],
"event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
"event_classes": [
"outcome_edit_cooccurs_with_results_posting"
],
"rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
"severity": "high",
"severity_pre_timing": "high",
"timing_context": "late_recruitment",
"triage_label": "high",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/7/measure"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT01275677_v907_v908_bdf3fe64c69e",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2020-09"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2020-09-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2020-09-23"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2020-05-06"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2020-09-01"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2020-09-23",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/briefSummary",
"value": "This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with HER2-low invasive breast cancer.\nDrugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.\nGiving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells.\nMonoclonal antibodies, such as trastuzumab, can block cancer growth in different ways.\nSome block the ability of tumor cells to grow and spread.\nOthers find tumor cells and help kill them or carry tumor-killing substances to them.\nIt is not yet known whether combination chemotherapy is more effective with trastuzumab in treating HER2-low breast cancer."
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 3270
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Percentage of Patients Alive and Free From Invasive Disease (IDFS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Percentage of patients free from an invasive disease-free survival event where events include any invasive recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Percentage of Patients Alive and Disease-Free (DFS-DCIS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Percentage of patients free from a disease-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), second primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Percentage of Patients Alive and Free From Breast Cancer (BCFS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "Percentage of patients free from a breast cancer-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), or death from any cause."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Percentage of Patients Alive and Recurrence-Free (RFI)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "Percentage of patients free from a recurrence-free interval event where events include invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes)."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Percentage of Patients Alive and Free From Distant Recurrence (DRFI)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "Percentage of patients free from a distant recurrence-free interval event where events include distant recurrence or death from breast cancer (censored for deaths from other causes), regardless of occurrence of any intervening local or regional recurrences, contralateral breast cancers, or non-breast second primary cancer."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "Percentage of Patients Alive (Overall Survival)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"value": "5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "Percentage of patients alive."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Toxicity Assessed by Adverse Events"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"value": "Percentage of patients who ever experienced grade 2 or higher toxicites."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"value": "While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"value": "Change in HER2 mRNA Level"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
"value": "Fcgamma Receptor Polymorphism"
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/documentSection/largeDocumentModule/largeDocs/0/date",
"value": "2018-02-08"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"description": "B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.\nThe total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted.\nThe at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).",
"eventGroups": [
{
"deathsNumAffected": 48,
"deathsNumAtRisk": 1622,
"description": "Arm I (chemotherapy)",
"id": "EG000",
"otherNumAffected": 1362,
"otherNumAtRisk": 1615,
"seriousNumAffected": 31,
"seriousNumAtRisk": 1615,
"title": "Arm I (Chemotherapy)"
},
{
"deathsNumAffected": 61,
"deathsNumAtRisk": 1628,
"description": "Arm II (chemotherapy, trastuzumab)",
"id": "EG001",
"otherNumAffected": 1418,
"otherNumAtRisk": 1625,
"seriousNumAffected": 96,
"seriousNumAtRisk": 1625,
"title": "Arm II (Chemotherapy, Trastuzumab)"
}
],
"frequencyThreshold": "5",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 633,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 653,
"numAtRisk": 1625
}
],
"term": "Alopecia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 222,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 327,
"numAtRisk": 1625
}
],
"term": "Anemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 161,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 233,
"numAtRisk": 1625
}
],
"term": "Arthralgia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 228,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 221,
"numAtRisk": 1625
}
],
"term": "Bone pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 135,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 124,
"numAtRisk": 1625
}
],
"term": "Constipation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 80,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 136,
"numAtRisk": 1625
}
],
"term": "Cough"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 228,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 324,
"numAtRisk": 1625
}
],
"term": "Diarrhea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 629,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 644,
"numAtRisk": 1625
}
],
"term": "Fatigue"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 164,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 187,
"numAtRisk": 1625
}
],
"term": "Headache"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 103,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 196,
"numAtRisk": 1625
}
],
"term": "Hypertension"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 108,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 128,
"numAtRisk": 1625
}
],
"term": "Insomnia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 131,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 152,
"numAtRisk": 1625
}
],
"term": "Lymphocyte count decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 240,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 238,
"numAtRisk": 1625
}
],
"term": "Mucositis oral"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 196,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 222,
"numAtRisk": 1625
}
],
"term": "Myalgia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 408,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 377,
"numAtRisk": 1625
}
],
"term": "Nausea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 145,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 166,
"numAtRisk": 1625
}
],
"term": "Neutrophil count decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 279,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 321,
"numAtRisk": 1625
}
],
"term": "Peripheral sensory neuropathy"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 78,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 133,
"numAtRisk": 1625
}
],
"term": "Upper respiratory infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 141,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 129,
"numAtRisk": 1625
}
],
"term": "Vomiting"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 119,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 151,
"numAtRisk": 1625
}
],
"term": "White blood cell decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 164,
"numAtRisk": 1625
}
],
"term": "Ejection fraction decreased"
}
],
"seriousEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Adult respiratory distress syndrome"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Alanine aminotransferase increased (ALT/SGPT)"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Aspartate aminotransferase increased (AST/SGOT)"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Asystole"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Blood and lymphatic system disorders - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Catheter related infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 1625
}
],
"term": "Colonic perforation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Delirium"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 4,
"numAtRisk": 1625
}
],
"term": "Depression"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Diarrhea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Disseminated intravascular coagulation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Dyspnea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Erythema multiforme"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 18,
"numAtRisk": 1625
}
],
"term": "Heart failure"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Hepatobiliary disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Hepatic failure"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Hepatitis viral"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 1625
}
],
"term": "Hypercalcemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 4,
"numAtRisk": 1625
}
],
"term": "Hyperglycemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 1625
}
],
"term": "Hypertension"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Hypertriglyceridemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 1625
}
],
"term": "Hyperuricemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Hypocalcemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 6,
"numAtRisk": 1625
}
],
"term": "Hypokalemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Hypomagnesemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Hyponatremia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Hypotension"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 1625
}
],
"term": "Hypoxia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Injury, poisoning and procedural complications - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Intracranial hemorrhage"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 1625
}
],
"term": "Lipase increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Multi-organ failure"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 1625
}
],
"term": "Myelodysplastic syndrome"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 1625
}
],
"term": "Myocardial infarction"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 1625
}
],
"term": "Pericardial effusion"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 5,
"numAtRisk": 1625
}
],
"term": "Pneumonitis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Pneumothorax"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Pregnancy, puerperium and perinatal conditions",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 1625
}
],
"term": "Pregnancy, puerperium and perinatal conditions - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Psychosis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 1625
}
],
"term": "Respiratory failure"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 7,
"numAtRisk": 1625
}
],
"term": "Sepsis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Stroke"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Suicide attempt"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 1625
}
],
"term": "Supraventricular tachycardia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 1625
}
],
"term": "Syncope"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 1625
}
],
"term": "Thromboembolic event"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Typhlitis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Reproductive system and breast disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Vaginal dryness"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Ventricular tachycardia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Leukemia secondary to oncology chemotherapy"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 10,
"numAtRisk": 1625
}
],
"term": "Ejection fraction decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 1625
}
],
"term": "Acute coronary syndrome"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Upper gastrointestinal hemorrhage"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 1625
}
],
"term": "Enterocolitis infectious"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Lung infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Tricuspid valve disease"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Mitral valve disease"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Aortic valve disease"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 1625
}
],
"term": "Vascular access complication"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 1625
}
],
"term": "Small intestine infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 1625
}
],
"term": "Acute kidney injury"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE v4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 1615
},
{
"groupId": "EG001",
"numAffected": 29,
"numAtRisk": 1625
}
],
"term": "Left ventricular systolic dysfunction"
}
],
"timeFrame": "All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "1630"
},
{
"groupId": "BG001",
"value": "1640"
},
{
"groupId": "BG002",
"value": "3270"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "Arm I (chemotherapy)",
"id": "BG000",
"title": "Arm I (Chemotherapy)"
},
{
"description": "Arm II (chemotherapy, trastuzumab)",
"id": "BG001",
"title": "Arm II (Chemotherapy, Trastuzumab)"
},
{
"description": "Total of all reporting groups",
"id": "BG002",
"title": "Total"
}
],
"measures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"spread": "10.4",
"value": "52"
},
{
"groupId": "BG001",
"spread": "10.4",
"value": "52"
},
{
"groupId": "BG002",
"spread": "10.4",
"value": "52"
}
]
}
]
}
],
"dispersionType": "STANDARD_DEVIATION",
"paramType": "MEAN",
"title": "Age, Continuous",
"unitOfMeasure": "years"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "1630"
},
{
"groupId": "BG001",
"value": "1640"
},
{
"groupId": "BG002",
"value": "3270"
}
],
"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": "8"
},
{
"groupId": "BG001",
"value": "6"
},
{
"groupId": "BG002",
"value": "14"
}
],
"title": "American Indian or Alaska Native"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "63"
},
{
"groupId": "BG001",
"value": "61"
},
{
"groupId": "BG002",
"value": "124"
}
],
"title": "Asian"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "4"
},
{
"groupId": "BG001",
"value": "7"
},
{
"groupId": "BG002",
"value": "11"
}
],
"title": "Native Hawaiian or Other Pacific Islander"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "144"
},
{
"groupId": "BG001",
"value": "175"
},
{
"groupId": "BG002",
"value": "319"
}
],
"title": "Black or African American"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "1370"
},
{
"groupId": "BG001",
"value": "1354"
},
{
"groupId": "BG002",
"value": "2724"
}
],
"title": "White"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "9"
},
{
"groupId": "BG001",
"value": "10"
},
{
"groupId": "BG002",
"value": "19"
}
],
"title": "More than one race"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "32"
},
{
"groupId": "BG001",
"value": "27"
},
{
"groupId": "BG002",
"value": "59"
}
],
"title": "Unknown or Not Reported"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Race (NIH/OMB)",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "106"
},
{
"groupId": "BG002",
"value": "208"
}
],
"title": "Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "1488"
},
{
"groupId": "BG001",
"value": "1513"
},
{
"groupId": "BG002",
"value": "3001"
}
],
"title": "Not Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "40"
},
{
"groupId": "BG001",
"value": "21"
},
{
"groupId": "BG002",
"value": "61"
}
],
"title": "Unknown or Not Reported"
}
],
"title": "Mutually exclusive and exhaustive"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Race/Ethnicity, Customized",
"unitOfMeasure": "Participants"
}
]
},
"moreInfoModule": {
"certainAgreement": {
"piSponsorEmployee": false,
"restrictionType": "LTE60",
"restrictiveAgreement": true
},
"pointOfContact": {
"email": "langerj@nrgoncology.org",
"organization": "NRG Oncology",
"phone": "412-339-5300",
"title": "Director, Department of Regulatory Affairs"
}
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "89.2"
},
{
"groupId": "OG001",
"value": "89.8"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "1602"
},
{
"groupId": "OG001",
"value": "1598"
}
],
"units": "Participants"
}
],
"description": "Percentage of patients free from an invasive disease-free survival event where events include any invasive recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause.",
"groups": [
{
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>",
"id": "OG000",
"title": "Arm I (Chemotherapy)"
},
{
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>",
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)"
}
],
"paramType": "NUMBER",
"populationDescription": "Includes all at-risk patients with clinical follow up",
"reportingStatus": "POSTED",
"timeFrame": "5 years",
"title": "Percentage of Patients Alive and Free From Invasive Disease (IDFS)",
"type": "PRIMARY",
"unitOfMeasure": "percentage of patients"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "89.1"
},
{
"groupId": "OG001",
"value": "89.6"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "1602"
},
{
"groupId": "OG001",
"value": "1598"
}
],
"units": "Participants"
}
],
"description": "Percentage of patients free from a disease-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), second primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause.",
"groups": [
{
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>",
"id": "OG000",
"title": "Arm I (Chemotherapy)"
},
{
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>",
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)"
}
],
"paramType": "NUMBER",
"populationDescription": "Includes all at-risk patients with clinical follow-up",
"reportingStatus": "POSTED",
"timeFrame": "5 years",
"title": "Percentage of Patients Alive and Disease-Free (DFS-DCIS)",
"type": "SECONDARY",
"unitOfMeasure": "percentage of patients"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "91.0"
},
{
"groupId": "OG001",
"value": "90.7"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "1602"
},
{
"groupId": "OG001",
"value": "1598"
}
],
"units": "Participants"
}
],
"description": "Percentage of patients free from a breast cancer-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), or death from any cause.",
"groups": [
{
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>",
"id": "OG000",
"title": "Arm I (Chemotherapy)"
},
{
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>",
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)"
}
],
"paramType": "NUMBER",
"populationDescription": "Includes all at-risk patients with clinical follow up",
"reportingStatus": "POSTED",
"timeFrame": "5 years",
"title": "Percentage of Patients Alive and Free From Breast Cancer (BCFS)",
"type": "SECONDARY",
"unitOfMeasure": "percentage of patients"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "92.3"
},
{
"groupId": "OG001",
"value": "92.0"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "1602"
},
{
"groupId": "OG001",
"value": "1598"
}
],
"units": "Participants"
}
],
"description": "Percentage of patients free from a recurrence-free interval event where events include invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes).",
"groups": [
{
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>",
"id": "OG000",
"title": "Arm I (Chemotherapy)"
},
{
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>",
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)"
}
],
"paramType": "NUMBER",
"populationDescription": "Includes all at-risk patients with clinical follow-up",
"reportingStatus": "POSTED",
"timeFrame": "5 years",
"title": "Percentage of Patients Alive and Recurrence-Free (RFI)",
"type": "SECONDARY",
"unitOfMeasure": "percentage of patients"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "93.6"
},
{
"groupId": "OG001",
"value": "92.7"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "1602"
},
{
"groupId": "OG001",
"value": "1598"
}
],
"units": "Participants"
}
],
"description": "Percentage of patients free from a distant recurrence-free interval event where events include distant recurrence or death from breast cancer (censored for deaths from other causes), regardless of occurrence of any intervening local or regional recurrences, contralateral breast cancers, or non-breast second primary cancer.",
"groups": [
{
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>",
"id": "OG000",
"title": "Arm I (Chemotherapy)"
},
{
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>",
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)"
}
],
"paramType": "NUMBER",
"populationDescription": "Includes all at-risk patients with clinical follow-up",
"reportingStatus": "POSTED",
"timeFrame": "5 years",
"title": "Percentage of Patients Alive and Free From Distant Recurrence (DRFI)",
"type": "SECONDARY",
"unitOfMeasure": "percentage of patients"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "96.3"
},
{
"groupId": "OG001",
"value": "94.8"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "1603"
},
{
"groupId": "OG001",
"value": "1602"
}
],
"units": "Participants"
}
],
"description": "Percentage of patients alive.",
"groups": [
{
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>",
"id": "OG000",
"title": "Arm I (Chemotherapy)"
},
{
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>",
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)"
}
],
"paramType": "NUMBER",
"populationDescription": "Includes all at-risk patients with follow-up",
"reportingStatus": "POSTED",
"timeFrame": "5 years",
"title": "Percentage of Patients Alive (Overall Survival)",
"type": "SECONDARY",
"unitOfMeasure": "percentage of patients alive"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "90.9"
},
{
"groupId": "OG001",
"value": "94.1"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "1615"
},
{
"groupId": "OG001",
"value": "1625"
}
],
"units": "Participants"
}
],
"description": "Percentage of patients who ever experienced grade 2 or higher toxicites.",
"groups": [
{
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>",
"id": "OG000",
"title": "Arm I (Chemotherapy)"
},
{
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>",
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)"
}
],
"paramType": "NUMBER",
"populationDescription": "Includes all at-risk patients with clinical follow-up.",
"reportingStatus": "POSTED",
"timeFrame": "While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose.",
"title": "Toxicity Assessed by Adverse Events",
"type": "SECONDARY",
"unitOfMeasure": "percentage of patients"
},
{
"anticipatedPostingDate": "2022-01",
"denomUnitsSelected": "Participants",
"description": "The interaction between treatment effect and HER2 mRNA level will be evaluated in the proportional hazards model, which would include an indicator for treatment group and the HER2 mRNA level as a continuous variable, and the corresponding interaction term.\nThe log-hazard ratio plot for the interaction term with 95% confidence intervals will be used to determine the cut-off of the HER2 mRNA level that would determine a subset of the patients who would benefit from the adjuvant trastuzumab therapy.",
"reportingStatus": "NOT_POSTED",
"timeFrame": "From baseline to 24 months",
"title": "Change in HER2 mRNA Level",
"type": "SECONDARY"
},
{
"anticipatedPostingDate": "2022-01",
"denomUnitsSelected": "Participants",
"description": "The polymorphism of the Fcgamma 158 receptor gene will be dichotomized as V/V (valine) vs. other genotypes and the polymorphism of the Fcgamma 131 receptor gene will be dichotomized as H/H (histidine) vs. other genotypes to evaluate an interaction between treatment group and Fcgamma polymorphism.\nThe Kaplan-Meier method105 will be used to estimate the distribution of the primary endpoints stratified by the dichotomized subgroups, and the log-rank test106 will be used to statistically compare the time-to-event distributions.",
"reportingStatus": "NOT_POSTED",
"timeFrame": "From baseline to up to 24 months",
"title": "Fcgamma Receptor Polymorphism",
"type": "SECONDARY"
}
]
},
"participantFlowModule": {
"groups": [
{
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>",
"id": "FG000",
"title": "Arm I (Chemotherapy)"
},
{
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>",
"id": "FG001",
"title": "Arm II (Chemotherapy, Trastuzumab)"
}
],
"periods": [
{
"dropWithdraws": [
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
],
"type": "Not at risk for recurrence."
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "26"
},
{
"groupId": "FG001",
"numSubjects": "37"
}
],
"type": "No follow-up"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "4"
}
],
"type": "No clinical follow up."
}
],
"milestones": [
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1630"
},
{
"groupId": "FG001",
"numSubjects": "1640"
}
],
"type": "STARTED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1602"
},
{
"groupId": "FG001",
"numSubjects": "1598"
}
],
"type": "COMPLETED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "28"
},
{
"groupId": "FG001",
"numSubjects": "42"
}
],
"type": "NOT COMPLETED"
}
],
"title": "Overall Study"
}
]
}
}
}
],
"provenance": {
"from_snapshot_hash": "a219254bd24d2442d0fbde38e9baa02b0cc447da2708e379735391cca0ebe135",
"materiality_event_hash": "8d00182d1c80e48ef60025ab5eae8d0facd9ceca7affe7c830fe55738eaeac78",
"patch_hash": "4dd658fc2e7e8fc67e96ff7044f294c47bb630e0c1a342948254ec4b9fdd7731",
"patch_raw_hash": "8ae354c2100c1d29e6d9fb13e8fb07e9474d2219e10d012602cf6e7be077a67c",
"patch_source": "ctgov_internal_history",
"patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT01275677/history/907?patchToVersion=908",
"to_snapshot_hash": "04e26bee4924910dfc251a2c33982177ff6a9acfcff9763da2c23a04c00bd349"
},
"review_question": "What explains the enrollment change, and does the change affect interpretation of trial feasibility or power?",
"schema": "trialdiff.evidence_record",
"trial": {
"clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT01275677",
"nct_id": "NCT01275677"
},
"versions": {
"from_version": 907,
"submitted_date": "2020-09-01",
"to_version": 908
}
}