Evidence Record
evt_NCT01142401_v52_v53_9f41c4bcf7d7
NCT01142401 · Fulvestrant With or Without Bortezomib in Patients With Inoperable Locally Advanced or Metastatic Estrogen Receptor Positive 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: Medium Category
Timeline Shift
Versions
v52 to v53
Timing
Late Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 52 to version 53 for NCT01142401.
- The JSON Patch for this comparison has hash 6ab02099525c3a68b6e2fbab439c3bd98bee695e971f8c8808fccaeaefb504ae.
- The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.
- The deterministic triage label was medium; before timing adjustment it was medium.
- 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/overallStatus, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/completionDateStruct, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/1, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /annotationSection, /hasResults, /resultsSection.
- A timeline value changed and was classified by TrialDiff's timeline signal rules.
- An outcome path changed between versions 52 and 53 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_NCT01142401_v52_v53_9f41c4bcf7d7. ClinicalTrials.gov NCT01142401, versions 52-53. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/overallStatus
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/completionDateStruct
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/primaryOutcomes/1
/protocolSection/outcomesModule/secondaryOutcomes/0/measure
/protocolSection/outcomesModule/secondaryOutcomes/0/description
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/1/measure
/protocolSection/outcomesModule/secondaryOutcomes/1/description
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/2/measure
/protocolSection/outcomesModule/secondaryOutcomes/2/description
/protocolSection/outcomesModule/secondaryOutcomes/3/measure
/protocolSection/outcomesModule/secondaryOutcomes/3/description
/annotationSection
/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_NCT01142401_v52_v53_3a9fdfd6b507
- Patch hash
6ab02099525c3a68b6e2fbab439c3bd98bee695e971f8c8808fccaeaefb504ae- Canonical hash
144220ab31aff69677aef90f939565b93d456de745a708277f682a416f165113- Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621- From snapshot
2efd0eafcdc1b126e1b458040fa91796a13adf5c715803f8f9e42287f8790b59- To snapshot
Unavailable- 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/overallStatus",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/completionDateStruct",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/statusModule/resultsFirstSubmitQcDate",
"/protocolSection/statusModule/resultsFirstPostDateStruct",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/1",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"/annotationSection",
"/hasResults",
"/resultsSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT01142401_v52_v53_9f41c4bcf7d7. ClinicalTrials.gov NCT01142401, versions 52-53. 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 52 to version 53 for NCT01142401.",
"The JSON Patch for this comparison has hash 6ab02099525c3a68b6e2fbab439c3bd98bee695e971f8c8808fccaeaefb504ae.",
"The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
"The deterministic triage label was medium; before timing adjustment it was medium.",
"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/overallStatus, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/completionDateStruct, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/1, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /annotationSection, /hasResults, /resultsSection.",
"A timeline value changed and was classified by TrialDiff's timeline signal rules.",
"An outcome path changed between versions 52 and 53 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"timeline_shift",
"results_reconciliation"
],
"category": "timeline_shift",
"deterministic_rules": [],
"event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
"event_classes": [
"outcome_edit_cooccurs_with_results_posting"
],
"rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
"severity": "medium",
"severity_pre_timing": "medium",
"timing_context": "late_recruitment",
"triage_label": "medium",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "timeline_shift",
"date_struct": "completionDateStruct",
"direction": "unknown",
"new_type": "ACTUAL",
"new_value": "2021-01-08",
"old_type": null,
"old_value": null,
"path": "/protocolSection/statusModule/completionDateStruct",
"reason": "date_unparsed_or_missing",
"severity": "medium",
"signal": "timeline_shift"
},
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/1",
"/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/3/description",
"/protocolSection/outcomesModule/secondaryOutcomes/3/measure"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT01142401_v52_v53_9f41c4bcf7d7",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2023-11"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
"value": "COMPLETED"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2023-11-03"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2023-11-27"
},
{
"op": "add",
"path": "/protocolSection/statusModule/completionDateStruct",
"value": {
"date": "2021-01-08",
"type": "ACTUAL"
}
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2021-05-11"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2023-11-03"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2023-11-27",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Number of Participants With Progression Free Survival (PFS) at 12 Months"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "The number of patients, treated with fulvestrant alone and fulvestrant plus bortezomib, who remained progression-free (Arms A vs. B).\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "At 12 months"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1",
"value": {
"measure": "Number of Participants With Progression Free Survival (PFS) at 6 Months",
"timeFrame": "At 6 months"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Clinical Benefit Rate (CBR) of Adding Bortezomib to Fulvestrant in Arm C"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "This outcome measure determined if the addition of bortezomib to fulvestrant improved the clinical benefit rate (defined as objective response plus stable disease for at least 24 weeks from day+1).\nClinical Benefit Rate (CBR) is defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "Up to 24 weeks"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Number of Participants Who Survived Until Study End (up to 7 Years)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "Tabulation of the number of participants who survived from the date of first treatment until study end (up to 7 years)."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "From first treatment day until study end, assessed up to 7 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Progression Free Survival at 24 Weeks (Arm C)"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Frequency of Most Common Toxicities"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "Most common toxicities in the fulvestrant arm alone (Arm A) and the fulvestrant/bortezomib combination arm (Arm B).\nMost common toxicities are defined as adverse events having occurred in >10% of the participants within either (or both) Arm A or Arm B."
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"description": "A 5% frequency threshold was set for the reporting of non-Serious Adverse Events (NSAEs) for this study.\nIf the occurrence of an adverse event was observed in >5% of participants in any of the three treatment arms the event was reported for all three arms.",
"eventGroups": [
{
"deathsNumAffected": 11,
"deathsNumAtRisk": 59,
"description": "<p>Patients received fulvestrant IM on day 1 (days -14, 1, and 15 of course 1 only).\nCourses were repeated every 28 days in the absence of disease progression or unacceptable toxicity.\nPatients with progressive disease may have crossed over to another treatment group (Arm C).</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "EG000",
"otherNumAffected": 59,
"otherNumAtRisk": 59,
"seriousNumAffected": 9,
"seriousNumAtRisk": 59,
"title": "Arm A: Fulvestrant Alone"
},
{
"deathsNumAffected": 15,
"deathsNumAtRisk": 57,
"description": "<p>Patients received fulvestrant IM as in Arm A and bortezomib IV on days 1, 8, and 15.\nCourses were repeated every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>Bortezomib: Given IV</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "EG001",
"otherNumAffected": 57,
"otherNumAtRisk": 57,
"seriousNumAffected": 6,
"seriousNumAtRisk": 57,
"title": "Arm B: Fulvestrant + Bortezomib"
},
{
"deathsNumAffected": 9,
"deathsNumAtRisk": 27,
"description": "<p>Patients who crossed over from Arm A at progression received fulvestrant IM on day 1 and bortezomib IM on days 1, 8, and 15.\nCourses were repeated every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>Bortezomib: Given IV</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "EG002",
"otherNumAffected": 27,
"otherNumAtRisk": 27,
"seriousNumAffected": 5,
"seriousNumAtRisk": 27,
"title": "Arm C: Crossover From Arm A at Progression to Fulvestrant + Bortezomib"
}
],
"frequencyThreshold": "5",
"otherEvents": [
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 11,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 4,
"numAtRisk": 27
}
],
"term": "Anxiety"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Depression, Seasonal Depression",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 9,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 5,
"numAtRisk": 27
}
],
"term": "Depression"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 19,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 24,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 12,
"numAtRisk": 27
}
],
"term": "Anemia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 17,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 6,
"numAtRisk": 27
}
],
"term": "Neutropenia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 24,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 35,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 15,
"numAtRisk": 27
}
],
"term": "Thrombocytopenia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 25,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 29,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 12,
"numAtRisk": 27
}
],
"term": "Hyperglycemia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 7,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27
}
],
"term": "Hypoglycemia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 15,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 18,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 6,
"numAtRisk": 27
}
],
"term": "SGOT_AST-High"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 12,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 5,
"numAtRisk": 27
}
],
"term": "SGPT_ALT-High"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 6,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27
}
],
"term": "Hyponatremia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 16,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 34,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 12,
"numAtRisk": 27
}
],
"term": "Nausea"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 17,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 6,
"numAtRisk": 27
}
],
"term": "Vomiting"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 27,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 14,
"numAtRisk": 27
}
],
"term": "Diarrhea"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 20,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 26,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 11,
"numAtRisk": 27
}
],
"term": "Constipation"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 10,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27
}
],
"term": "Heartburn/Dyspepsia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 13,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 4,
"numAtRisk": 27
}
],
"term": "Anorexia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 14,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 7,
"numAtRisk": 27
}
],
"term": "Headache"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 35,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 31,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 10,
"numAtRisk": 27
}
],
"term": "Pain"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Neuropathy-Pain; Neuropathy-Motor; Neuropathy-Sensory",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 18,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 28,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 8,
"numAtRisk": 27
}
],
"term": "Peripheral Neuropathy"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 6,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 27
}
],
"term": "Rash/Desquamation"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 14,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 7,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 4,
"numAtRisk": 27
}
],
"term": "Injection Site Reaction"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 9,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27
}
],
"term": "Pruritis"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 19,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 11,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 6,
"numAtRisk": 27
}
],
"term": "Dyspnea"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 17,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 13,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 27
}
],
"term": "Cough"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 21,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 16,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 7,
"numAtRisk": 27
}
],
"term": "Arthralgia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 10,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 4,
"numAtRisk": 27
}
],
"term": "Myalgia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 33,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 32,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 11,
"numAtRisk": 27
}
],
"term": "Fatigue"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 11,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 21,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 7,
"numAtRisk": 27
}
],
"term": "Limb Edema"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 7,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27
}
],
"term": "Fever"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 15,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 20,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 6,
"numAtRisk": 27
}
],
"term": "Insomnia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 11,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 27
}
],
"term": "Dizziness"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 22,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 18,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 6,
"numAtRisk": 27
}
],
"term": "Hot Flashes"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 4,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 27
}
],
"term": "Creatinine increased"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 7,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27
}
],
"term": "Hypocalcemia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Absolute Neutrophil Count - low (Verbatim Term)",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 7,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27
}
],
"term": "Neutrophil Count Decreased"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Term",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 4,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27
}
],
"term": "Infection with unknown Absolute Neutrophil Count"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Term - Rigors/chills",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 4,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27
}
],
"term": "Chills"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Term",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27
}
],
"term": "Creatinine-Low"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Term",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27
}
],
"term": "Total Bilirubin Low"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27
}
],
"term": "Alopecia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Blurred Vision, Vision Changes",
"organSystem": "Eye disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 5,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27
}
],
"term": "Blurred Vision"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Chronic Kidney Disease, Chronic Renal Disease",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27
}
],
"term": "Chronic Kidney Disease"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 7,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27
}
],
"term": "Dry Eye"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27
}
],
"term": "Dry Mouth"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27
}
],
"term": "Dry Skin"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Dysgeusia, Taste Changes",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27
}
],
"term": "Dysgeusia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27
}
],
"term": "Epistaxis"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27
}
],
"term": "Fall"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Flu Like Symptoms, Flu Symptoms, Flu Like Feeling",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27
}
],
"term": "Flu Like Symptoms"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Hypertension, Hypertension-transient, High Blood Pressure",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 12,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 8,
"numAtRisk": 27
}
],
"term": "Hypertension"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 4,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27
}
],
"term": "Malaise"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Mouth Sore, Mucositis Oral, Mucositis, Mucosal Infection (System Organ Class: Infections and Infestations)",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 6,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 27
}
],
"term": "Mucositis Oral"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "General finger/hand numbness due to either Reynaud's syndrome or carpal tunnel",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27
}
],
"term": "Numbness - fingers"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Rash Acneiform, Rash Maculo-papular, Purpura, Perioral Swelling, Skin Hyperpigmentation, Skin Redness, Shingles, Papulopustular Rash (Infections and Infestations - System Organ Class)",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 13,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 27
}
],
"term": "Rash (General, not otherwise specified)"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Term",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 4,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27
}
],
"term": "Pressure - left pubic area"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 5,
"numAtRisk": 27
}
],
"term": "Weight Loss"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Laryngeal Inflammation, Sore Throat",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 5,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27
}
],
"term": "Laryngeal Inflammation"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27
}
],
"term": "Toothache"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Stye(s), Eyelid Function Disorder, Sore on Eyelid/Pruritis, Watering Eyes, Excessive Tearing (Right Eye), Glaucoma, Periocular Swelling, Cellulitis (Right Eye), Eye Infection (System Organ Class: Infections and Infestations)",
"organSystem": "Eye disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 7,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 27
}
],
"term": "Eye Disorders (not otherwise specified)"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Urinary Frequency, Urinary Incontinence, Urinary Retention, Urinary Tract Obstruction, Urinary Urgency, Urine Odor, Urinary Tract Infection (System Organ Class: Infections and Infestations)",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 6,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27
}
],
"term": "Urinary Disorders (General)"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Vaginal Discharge, Vaginal Dryness, Vaginal Hemorrhage, Vaginal Odor, Vulval Infection (System Organ Class: Infections and Infestations), Vaginal Infection (System Organ Class: Infections and Infestations), Bacterial Vaginosis",
"organSystem": "Reproductive system and breast disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27
}
],
"term": "Reproductive system and breast disorders (General)"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim: Allergic Rhinitis, Nasal Congestion, Sinus Disorder/Common Cold, Sinus Congestion, Rhinorrhea, Seasonal Allergies (sinus).\nSinusitis, Respiratory Infection and Upper Respiratory Infection (System Organ Class: Infections and Infestations)",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 13,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 8,
"numAtRisk": 27
}
],
"term": "Upper Respiratory Disorders (General)"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Pneumonitis, Asthma, Bronchospasm, Hemoptysis, Bronchial Infection (System Organ Class: Infections and Infestations), Pleural Infection (System Organ Class: Infections and Infestations)",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27
}
],
"term": "Lower Respiratory Disorders (General, not otherwise specified)"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Ear Pain, Ear Fullness/Pressure, Tinnitus, Otitis Media (System Organ Class: Infections and Infestations)",
"organSystem": "Ear and labyrinth disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27
}
],
"term": "Ear Disorders (General)"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Skin Infection, Skin Infection (Viral), Skin Infection (insect bite), Cellulitis, Cellulitis around pleurex site",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 27
}
],
"term": "Skin Infections (General)"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Infection, Infection localized (big toe), Infection (other), Lip Infection, Nail Infection, Soft Tissue Infection, Herpes",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 4,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27
}
],
"term": "Infections (General), not otherwise specified"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim: Generalized Muscle Weakness, Muscle Cramping, Muscle Spasms, Muscle Tension, Muscle Cramping - back, Muscle Weakness - lower limb, Pain - left deltoid muscle, Leg Cramps, Leg Pain, Bone Pain, Jaw Clicking, Osteonecrosis-Jaw, Neck Tightness",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 10,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 10,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 7,
"numAtRisk": 27
}
],
"term": "Musculoskeletal Pain Disorders (not otherwise specified)"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Sinus Tachycardia, Rapid Heartbeat",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27
}
],
"term": "Sinus Tachycardia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "Verbatim Terms: Basal Cell Carcinoma, Squamous Cell Carcinoma",
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27
}
],
"term": "Carcinomas"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 24,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 35,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 15,
"numAtRisk": 27
}
],
"term": "Hemoglobin - Low"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 19,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 24,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 12,
"numAtRisk": 27
}
],
"term": "White Blood Cells Decreased"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 59
},
{
"groupId": "EG001",
"numAffected": 17,
"numAtRisk": 57
},
{
"groupId": "EG002",
"numAffected": 6,
"numAtRisk": 27
}
],
"term": "Platelet Count Decreased"
}
],
"seriousEvents": [
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "CTCAE Grade 5, unrelated to study drug",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 59,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 57,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27,
"numEvents": 0
}
],
"term": "Cardiac Arrest"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "CTCAE Grade 3",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 59,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 57,
"numEvents": 2
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27,
"numEvents": 1
}
],
"term": "Nausea"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "CTCAE Grade 3",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 59,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 57,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27,
"numEvents": 1
}
],
"term": "Vomiting"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "CTCAE Grade 4",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 59,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 57,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27,
"numEvents": 0
}
],
"term": "Hyponatremia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "CTCAE Grade 3",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 59,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 57,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 27,
"numEvents": 1
}
],
"term": "Hypotension"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "CTCAE Grade 3",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 59,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 57,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27,
"numEvents": 0
}
],
"term": "Hyperglycemia"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "CTCAE Grade 3",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 59,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 57,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27,
"numEvents": 0
}
],
"term": "Cardiac Disorder (Unspecified)"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "CTCAE Grade 3",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 59,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 57,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27,
"numEvents": 0
}
],
"term": "Dehydration"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "CTCAE Grade 3",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 59,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 57,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 27,
"numEvents": 2
}
],
"term": "Pleural Effusion"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "CTCAE Grade 3",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 59,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 57,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27,
"numEvents": 0
}
],
"term": "Spinal Fracture"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "CTCAE Grade 3",
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 59,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 57,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27,
"numEvents": 0
}
],
"term": "Endometrial cancer"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"notes": "CTCAE Grade 3",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 59,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 57,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 27,
"numEvents": 0
}
],
"term": "Hip Fracture"
}
],
"timeFrame": "Up to 7 years"
},
"baselineCharacteristicsModule": {
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "59"
},
{
"groupId": "BG001",
"value": "57"
},
{
"groupId": "BG002",
"value": "116"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "<p>Patients received fulvestrant IM on day 1 (days -14, 1, and 15 of course 1 only).\nCourses repeated every 28 days in the absence of disease progression or unacceptable toxicity.\nPatients with progressive disease may crossover to Arm C.</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "BG000",
"title": "Arm A: Fulvestrant"
},
{
"description": "<p>Patients received fulvestrant IM as in Arm A and bortezomib IV on days 1, 8, and 15.\nCourses repeated every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>Bortezomib: Given IV</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "BG001",
"title": "Arm B: Fulvestrant + Bortezomib"
},
{
"description": "Total of all reporting groups",
"id": "BG002",
"title": "Total"
}
],
"measures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"lowerLimit": "31",
"upperLimit": "83",
"value": "57"
},
{
"groupId": "BG001",
"lowerLimit": "31",
"upperLimit": "80",
"value": "59"
},
{
"groupId": "BG002",
"lowerLimit": "31",
"upperLimit": "80",
"value": "57"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "59"
},
{
"groupId": "BG001",
"value": "57"
},
{
"groupId": "BG002",
"value": "116"
}
],
"units": "Participants"
}
]
}
],
"dispersionType": "FULL_RANGE",
"paramType": "MEDIAN",
"title": "Age, Continuous",
"unitOfMeasure": "years"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "59"
},
{
"groupId": "BG001",
"value": "57"
},
{
"groupId": "BG002",
"value": "116"
}
],
"title": "Female"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"title": "Male"
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "59"
},
{
"groupId": "BG001",
"value": "57"
},
{
"groupId": "BG002",
"value": "116"
}
],
"units": "Participants"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Sex: Female, Male",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG002",
"value": "0"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"units": "Participants"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"populationDescription": "Race and Ethnicity were not collected from any participant.",
"title": "Race and Ethnicity Not Collected",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "59"
},
{
"groupId": "BG001",
"value": "57"
},
{
"groupId": "BG002",
"value": "116"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "59"
},
{
"groupId": "BG001",
"value": "57"
},
{
"groupId": "BG002",
"value": "116"
}
],
"units": "Participants"
}
],
"title": "United States"
}
],
"paramType": "NUMBER",
"title": "Region of Enrollment",
"unitOfMeasure": "participants"
}
]
},
"moreInfoModule": {
"certainAgreement": {
"piSponsorEmployee": false,
"restrictionType": "LTE60",
"restrictiveAgreement": true
},
"pointOfContact": {
"email": "joseph.sparano@mssm.edu",
"organization": "Icahn School of Medicine at Mount Sinai",
"phone": "212-241-3300",
"title": "Joseph Sparano, MD"
}
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8"
},
{
"groupId": "OG001",
"value": "16"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "59"
},
{
"groupId": "OG001",
"value": "57"
}
],
"units": "Participants"
}
],
"description": "The number of patients, treated with fulvestrant alone and fulvestrant plus bortezomib, who remained progression-free (Arms A vs. B).\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions",
"groups": [
{
"description": "<p>Patients received fulvestrant IM on day 1 (days -14, 1, and 15 of course 1 only).\nCourses were repeated every 28 days in the absence of disease progression or unacceptable toxicity.\nPatients with progressive disease may have crossed over into another treatment group (Arm C).</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "OG000",
"title": "Arm A: Fulvestrant"
},
{
"description": "<p>Patients received fulvestrant as in arm A and bortezomib IV on days 1, 8, and 15.\nCourses were repeated every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>Bortezomib: Given IV</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "OG001",
"title": "Arm B: Fulvestrant + Bortezomib"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"reportingStatus": "POSTED",
"timeFrame": "At 12 months",
"title": "Number of Participants With Progression Free Survival (PFS) at 12 Months",
"type": "PRIMARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "16"
},
{
"groupId": "OG001",
"value": "22"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "59"
},
{
"groupId": "OG001",
"value": "57"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "<p>Patients received fulvestrant IM on day 1 (days -14, 1, and 15 of course 1 only).\nCourses were repeated every 28 days in the absence of disease progression or unacceptable toxicity.\nPatients with progressive disease may have crossed over into another treatment group (Arm C).</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "OG000",
"title": "Arm A: Fulvestrant"
},
{
"description": "<p>Patients received fulvestrant IM as in Arm A and bortezomib IV on days 1, 8, and 15.\nCourses repeated every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>Bortezomib: Given IV</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "OG001",
"title": "Arm B: Fulvestrant + Bortezomib"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"reportingStatus": "POSTED",
"timeFrame": "At 6 months",
"title": "Number of Participants With Progression Free Survival (PFS) at 6 Months",
"type": "PRIMARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "5"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "27"
}
],
"units": "Participants"
}
],
"description": "This outcome measure determined if the addition of bortezomib to fulvestrant improved the clinical benefit rate (defined as objective response plus stable disease for at least 24 weeks from day+1).\nClinical Benefit Rate (CBR) is defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.",
"groups": [
{
"description": "Patients received fulvestrant IV on day 1 and bortezomib IM on days 1, 8, and 15.\nCourses repeated every 28 days in the absence of disease progression or unacceptable toxicity.",
"id": "OG000",
"title": "Arm C: Crossover From Arm A at Progression to Fulvestrant + Bortezomib"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"populationDescription": "# of participants randomized to Arm A (Fulvestrant alone) who crossed over to fulvestrant plus bortezomib at progression (Arm C) and had clinical benefit.",
"reportingStatus": "POSTED",
"timeFrame": "Up to 24 weeks",
"title": "Clinical Benefit Rate (CBR) of Adding Bortezomib to Fulvestrant in Arm C",
"type": "SECONDARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "39"
},
{
"groupId": "OG001",
"value": "42"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "59"
},
{
"groupId": "OG001",
"value": "57"
}
],
"units": "Participants"
}
],
"description": "Tabulation of the number of participants who survived from the date of first treatment until study end (up to 7 years).",
"groups": [
{
"description": "<p>Patients received fulvestrant IM on day 1 (days -14, 1, and 15 of course 1 only).\nCourses repeated every 28 days in the absence of disease progression or unacceptable toxicity.\nPatients with progressive disease may crossover to Arm C.</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "OG000",
"title": "Arm A: Fulvestrant Alone"
},
{
"description": "<p>Patients received fulvestrant IM as in Arm A and bortezomib IV on days 1, 8, and 15.\nCourses repeated every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>Bortezomib: Given IV</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "OG001",
"title": "Arm B: Fulvestrant + Bortezomib"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"reportingStatus": "POSTED",
"timeFrame": "From first treatment day until study end, assessed up to 7 years",
"title": "Number of Participants Who Survived Until Study End (up to 7 Years)",
"type": "SECONDARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "5"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "27"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "<p>Patients who crossed over from Arm A received fulvestrant IM on day 1 and bortezomib IV on days 1, 8, and 15.\nCourses repeated every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>Bortezomib: Given IV</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "OG000",
"title": "Arm C: Crossover From Arm A at Progression to Fulvestrant + Bortezomib"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"reportingStatus": "POSTED",
"timeFrame": "At 24 weeks",
"title": "Progression Free Survival at 24 Weeks (Arm C)",
"type": "SECONDARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "41"
},
{
"groupId": "OG001",
"value": "61"
}
]
}
],
"title": "Hemoglobin-Low"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "32"
},
{
"groupId": "OG001",
"value": "42"
}
]
}
],
"title": "White Blood Cell-Low"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "44"
},
{
"groupId": "OG001",
"value": "51"
}
]
}
],
"title": "Hyperglycemia/Glucose-High"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "5"
},
{
"groupId": "OG001",
"value": "12"
}
]
}
],
"title": "Hypoglycemia/Glucose-Low"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "25"
},
{
"groupId": "OG001",
"value": "32"
}
]
}
],
"title": "SGOT (AST-High)"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "14"
},
{
"groupId": "OG001",
"value": "21"
}
]
}
],
"title": "SGPT (ALT-High)"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "10"
},
{
"groupId": "OG001",
"value": "12"
}
]
}
],
"title": "Neutrophil Count Decreased/ANC-low"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8"
},
{
"groupId": "OG001",
"value": "30"
}
]
}
],
"title": "Platelet Count Decreased/Platelets-Low"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "10"
},
{
"groupId": "OG001",
"value": "12"
}
]
}
],
"title": "Hypocalcemia/Calcium-Low"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8"
},
{
"groupId": "OG001",
"value": "12"
}
]
}
],
"title": "Hyponatremia/Sodium-Low"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "29"
},
{
"groupId": "OG001",
"value": "63"
}
]
}
],
"title": "Nausea"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "14"
},
{
"groupId": "OG001",
"value": "32"
}
]
}
],
"title": "Vomiting"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8"
},
{
"groupId": "OG001",
"value": "47"
}
]
}
],
"title": "Diarrhea"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "34"
},
{
"groupId": "OG001",
"value": "46"
}
]
}
],
"title": "Constipation"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "10"
},
{
"groupId": "OG001",
"value": "18"
}
]
}
],
"title": "Heartburn/Dyspepsia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "15"
},
{
"groupId": "OG001",
"value": "23"
}
]
}
],
"title": "Anorexia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12"
},
{
"groupId": "OG001",
"value": "25"
}
]
}
],
"title": "Headache"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "59"
},
{
"groupId": "OG001",
"value": "54"
}
]
}
],
"title": "Pain (general)"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "31"
},
{
"groupId": "OG001",
"value": "49"
}
]
}
],
"title": "Peripheral Neuropathy (Motor, Pain, Sensory)"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "24"
},
{
"groupId": "OG001",
"value": "12"
}
]
}
],
"title": "Injection Site Reaction"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "32"
},
{
"groupId": "OG001",
"value": "19"
}
]
}
],
"title": "Dyspnea"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "29"
},
{
"groupId": "OG001",
"value": "23"
}
]
}
],
"title": "Cough"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "56"
},
{
"groupId": "OG001",
"value": "56"
}
]
}
],
"title": "Fatigue"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "19"
},
{
"groupId": "OG001",
"value": "37"
}
]
}
],
"title": "Limb Edema"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "25"
},
{
"groupId": "OG001",
"value": "35"
}
]
}
],
"title": "Insomnia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "37"
},
{
"groupId": "OG001",
"value": "32"
}
]
}
],
"title": "Hot Flashes"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "7"
},
{
"groupId": "OG001",
"value": "19"
}
]
}
],
"title": "Dizziness"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "36"
},
{
"groupId": "OG001",
"value": "28"
}
]
}
],
"title": "Arthralgia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "10"
},
{
"groupId": "OG001",
"value": "18"
}
]
}
],
"title": "Myalgia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8"
},
{
"groupId": "OG001",
"value": "19"
}
]
}
],
"title": "Anxiety"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "15"
},
{
"groupId": "OG001",
"value": "12"
}
]
}
],
"title": "Fever"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "7"
},
{
"groupId": "OG001",
"value": "16"
}
]
}
],
"title": "Pruritis"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8"
},
{
"groupId": "OG001",
"value": "11"
}
]
}
],
"title": "Rash/Desquamation"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8"
},
{
"groupId": "OG001",
"value": "16"
}
]
}
],
"title": "Depression"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "32"
},
{
"groupId": "OG001",
"value": "42"
}
]
}
],
"title": "Anemia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "12"
}
]
}
],
"title": "Dry Eye"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12"
},
{
"groupId": "OG001",
"value": "21"
}
]
}
],
"title": "Hypertension"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "7"
},
{
"groupId": "OG001",
"value": "23"
}
]
}
],
"title": "Rash (General)"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "7"
},
{
"groupId": "OG001",
"value": "12"
}
]
}
],
"title": "Eye Disorders (not otherwise specified)"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "15"
},
{
"groupId": "OG001",
"value": "11"
}
]
}
],
"title": "Urinary Disorders (General)"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "41"
},
{
"groupId": "OG001",
"value": "61"
}
]
}
],
"title": "Thrombocytopenia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8"
},
{
"groupId": "OG001",
"value": "30"
}
]
}
],
"title": "Neutropenia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12"
},
{
"groupId": "OG001",
"value": "23"
}
]
}
],
"title": "Upper Respiratory Disorders (General)"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "17"
},
{
"groupId": "OG001",
"value": "18"
}
]
}
],
"title": "Musculoskeletal Pain Disorders (not otherwise specified)"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8"
},
{
"groupId": "OG001",
"value": "11"
}
]
}
],
"title": "Mucositis Oral"
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "59"
},
{
"groupId": "OG001",
"value": "57"
}
],
"units": "Participants"
}
],
"description": "Most common toxicities in the fulvestrant arm alone (Arm A) and the fulvestrant/bortezomib combination arm (Arm B).\nMost common toxicities are defined as adverse events having occurred in >10% of the participants within either (or both) Arm A or Arm B.",
"groups": [
{
"description": "<p>Patients received fulvestrant IM on day 1 (days -14, 1, and 15 of course 1 only).\nCourses repeated every 28 days in the absence of disease progression or unacceptable toxicity.\nPatients with progressive disease may crossover to Arm C.</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "OG000",
"title": "Arm A: Fulvestrant"
},
{
"description": "<p>Patients received fulvestrant IM as in arm A and bortezomib IV on days 1, 8, and 15.\nCourses repeated every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>Bortezomib: Given IV</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "OG001",
"title": "Arm B: Fulvestrant + Bortezomib"
}
],
"paramType": "NUMBER",
"reportingStatus": "POSTED",
"timeFrame": "Up to 7 years",
"title": "Frequency of Most Common Toxicities",
"type": "SECONDARY",
"unitOfMeasure": "percentage of participants"
}
]
},
"participantFlowModule": {
"groups": [
{
"description": "<p>Patients received fulvestrant IM on day 1 (days -14, 1, and 15 of course 1 only).\nCourses repeated every 28 days in the absence of disease progression or unacceptable toxicity.\nPatients with progressive disease may crossover to Arm C.</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "FG000",
"title": "Arm A: Fulvestrant Alone"
},
{
"description": "<p>Patients received fulvestrant IM as in Arm A and bortezomib IV on days 1, 8, and 15.\nCourses repeated every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>Bortezomib: Given IV</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "FG001",
"title": "Arm B: Fulvestrant + Bortezomib"
},
{
"description": "<p>Patients who crossed over from Arm A received fulvestrant IM on day 1 and bortezomib IV on days 1, 8, and 15.\nCourses repeated every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>Bortezomib: Given IV</p><p>Fulvestrant: Given IM</p><p>Laboratory Biomarker Analysis: Correlative studies</p>",
"id": "FG002",
"title": "Arm C: Crossover From Arm A at Progression to Fulvestrant + Bortezomib"
}
],
"periods": [
{
"milestones": [
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "59"
},
{
"groupId": "FG001",
"numSubjects": "59"
},
{
"groupId": "FG002",
"numSubjects": "0"
}
],
"type": "STARTED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "59"
},
{
"groupId": "FG001",
"numSubjects": "57"
},
{
"groupId": "FG002",
"numSubjects": "0"
}
],
"type": "COMPLETED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "2"
},
{
"groupId": "FG002",
"numSubjects": "0"
}
],
"type": "NOT COMPLETED"
}
],
"title": "Randomized Phase"
},
{
"milestones": [
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
},
{
"groupId": "FG002",
"numSubjects": "27"
}
],
"type": "STARTED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
},
{
"groupId": "FG002",
"numSubjects": "27"
}
],
"type": "COMPLETED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
},
{
"groupId": "FG002",
"numSubjects": "0"
}
],
"type": "NOT COMPLETED"
}
],
"title": "Crossover Phase"
}
],
"preAssignmentDetails": "118 postmenopausal women with ER-positive metastatic breast cancer resistant to aromatase inhibitors (AIs) were randomized to fulvestrant alone (Arm A) or in combination with bortezomib (Arm B).\nTwo patients randomized to Arm B never received protocol therapy.\nOf 59 patients randomized to fulvestrant alone, Arm A, 27 crossed over to receive fulvestrant plus bortezomib (Arm C) at progression on fulvestrant alone.",
"recruitmentDetails": "118 patients were enrolled from 17 institutions between May 2010 and October 2013"
}
}
}
],
"provenance": {
"from_snapshot_hash": "2efd0eafcdc1b126e1b458040fa91796a13adf5c715803f8f9e42287f8790b59",
"materiality_event_hash": "638b4163258511c43d0a9be006eca63da89e5d6eefe6292f3d6beebc89d06e0b",
"patch_hash": "6ab02099525c3a68b6e2fbab439c3bd98bee695e971f8c8808fccaeaefb504ae",
"patch_raw_hash": "5fa59a2cb06b73f7fa18621e9b905e664d37c37d382ad30c39e6102ba4556d3c",
"patch_source": "ctgov_internal_history",
"patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT01142401/history/52?patchToVersion=53",
"to_snapshot_hash": null
},
"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/NCT01142401",
"nct_id": "NCT01142401"
},
"versions": {
"from_version": 52,
"submitted_date": "2023-11-03",
"to_version": 53
}
}