NCT01142401
Version 52 to 53 · National Cancer Institute (NCI)
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[
{
"path": "/protocolSection/statusModule/completionDateStruct",
"reason": "date_unparsed_or_missing",
"signal": "timeline_shift",
"category": "timeline_shift",
"new_type": "ACTUAL",
"old_type": null,
"severity": "medium",
"direction": "unknown",
"new_value": "2021-01-08",
"old_value": null,
"date_struct": "completionDateStruct"
},
{
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
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"signal": "results_reconciliation_outcome_suppression",
"category": "results_reconciliation",
"severity": "low"
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] 5fa59a2cb06b73f7fa18621e9b905e664d37c37d382ad30c39e6102ba4556d3c/protocolSection/outcomesModule/primaryOutcomes/0/measure primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Progression free survival (PFS)
Number of Participants With Progression Free Survival (PFS) at 12 Months
/protocolSection/outcomesModule/primaryOutcomes/0/description primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. The PFS distributions of the two treatment arms will be estimated by Kaplan-Meier. PFS distributions will be compared by an unstratified log-rank test. Ninety-five percent confidence intervals for the Kaplan-Meier PFS estimates will be calculated using Greenwood's formulae.
The number of patients, treated with fulvestrant alone and fulvestrant plus bortezomib, who remained progression-free (Arms A vs. B). Progression 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
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. From first treatment day until objective or disease progression or death from any cause, assessed up to 7 years
At 12 months
/protocolSection/outcomesModule/primaryOutcomes/1 primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. {
"measure": "Number of Participants With Progression Free Survival (PFS) at 6 Months",
"timeFrame": "At 6 months"
} /protocolSection/outcomesModule/secondaryOutcomes/0/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Clinical benefit rate (CBR) (complete response [CR], partial response [PR], or stable disease [SD] >= 24 weeks), evaluated according to Response Evaluation Criteria in Solid Tumors
Clinical Benefit Rate (CBR) of Adding Bortezomib to Fulvestrant in Arm C
/protocolSection/outcomesModule/secondaryOutcomes/0/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Ninety-five percent confidence intervals will be calculated for the clinical benefit response proportion in each arm via binomial proportions. Comparison of the clinical benefit rate between the treatment arms will be performed by the chi-square test or Fisher's exact test, as appropriate.
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). Clinical 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.
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Up to 7 years
Up to 24 weeks
/protocolSection/outcomesModule/secondaryOutcomes/1/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Overall survival
Number of Participants Who Survived Until Study End (up to 7 Years)
/protocolSection/outcomesModule/secondaryOutcomes/1/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Estimated using the Kaplan-Meier method. The comparison of the overall survival distributions between the treatment arms will be performed by the log-rank test.
Tabulation of the number of participants who survived from the date of first treatment until study end (up to 7 years).
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. The time from first treatment day until death, assessed up to 7 years
From first treatment day until study end, assessed up to 7 years
/protocolSection/outcomesModule/secondaryOutcomes/2/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Percentage progression-free
Progression Free Survival at 24 Weeks (Arm C)
/protocolSection/outcomesModule/secondaryOutcomes/2/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Ninety-five percent confidence intervals will be calculated for the percent progression-free at 24 weeks in each arm via binomial proportions. Comparison of the percent progression-free at 24 weeks between the treatment arms will be performed by the chi-square test or Fisher's exact test, as appropriate.
/protocolSection/outcomesModule/secondaryOutcomes/3/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Frequency of Most Common Toxicities
/protocolSection/outcomesModule/secondaryOutcomes/3/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. The frequency of subjects experiencing toxicities will be tabulated.
Most common toxicities in the fulvestrant arm alone (Arm A) and the fulvestrant/bortezomib combination arm (Arm B). Most common toxicities are defined as adverse events having occurred in >10% of the participants within either (or both) Arm A or Arm B.
/protocolSection/statusModule/completionDateStruct completion_timeline_change Completion date changes are operational timeline signals. {
"date": "2021-01-08",
"type": "ACTUAL"
} /protocolSection/statusModule/statusVerifiedDate 2020-08
2023-11
/protocolSection/statusModule/lastUpdateSubmitDate 2020-08-14
2023-11-03
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2020-08-17
2023-11-27
/protocolSection/statusModule/resultsFirstSubmitDate 2021-05-11
/protocolSection/statusModule/resultsFirstSubmitQcDate 2023-11-03
/protocolSection/statusModule/resultsFirstPostDateStruct {
"date": "2023-11-27",
"type": "ACTUAL"
} /annotationSection {
"annotationModule": {
"unpostedAnnotation": {
"unpostedEvents": [
{
"date": "2021-05-11",
"type": "RELEASE"
},
{
"date": "2021-06-04",
"type": "RESET"
},
{
"date": "2021-07-08",
"type": "RELEASE"
},
{
"date": "2021-07-27",
"type": "RESET"
}
],
"unpostedResponsibleParty": "National Cancer Institute (NCI)"
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true
/resultsSection {
"moreInfoModule": {
"pointOfContact": {
"email": "joseph.sparano@mssm.edu",
"phone": "212-241-3300",
"title": "Joseph Sparano, MD",
"organization": "Icahn School of Medicine at Mount Sinai"
},
"certainAgreement": {
"restrictionType": "LTE60",
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
},
"adverseEventsModule": {
"timeFrame": "Up to 7 years",
"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": [
{
"id": "EG000",
"title": "Arm A: Fulvestrant Alone",
"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>",
"otherNumAtRisk": 59,
"deathsNumAtRisk": 59,
"otherNumAffected": 59,
"seriousNumAtRisk": 59,
"deathsNumAffected": 11,
"seriousNumAffected": 9
},
{
"id": "EG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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>",
"otherNumAtRisk": 57,
"deathsNumAtRisk": 57,
"otherNumAffected": 57,
"seriousNumAtRisk": 57,
"deathsNumAffected": 15,
"seriousNumAffected": 6
},
{
"id": "EG002",
"title": "Arm C: Crossover From Arm A at Progression to Fulvestrant + Bortezomib",
"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>",
"otherNumAtRisk": 27,
"deathsNumAtRisk": 27,
"otherNumAffected": 27,
"seriousNumAtRisk": 27,
"deathsNumAffected": 9,
"seriousNumAffected": 5
}
],
"otherEvents": [
{
"term": "Anxiety",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 11
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 4
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Depression",
"notes": "Verbatim Terms: Depression, Seasonal Depression",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 9
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 5
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Anemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 19
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 24
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 12
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Neutropenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 17
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Thrombocytopenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 24
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 35
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 15
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyperglycemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 25
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 29
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 12
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypoglycemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "SGOT_AST-High",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 15
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 18
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "SGPT_ALT-High",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 12
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 5
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyponatremia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 6
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 16
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 34
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 12
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 17
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Diarrhea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 27
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 14
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 20
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 26
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 11
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Heartburn/Dyspepsia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 10
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Anorexia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 13
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 4
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 14
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 7
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 35
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 31
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 10
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Peripheral Neuropathy",
"notes": "Verbatim Terms: Neuropathy-Pain; Neuropathy-Motor; Neuropathy-Sensory",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 18
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 28
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 8
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rash/Desquamation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 6
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Injection Site Reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 14
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 4
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pruritis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 9
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dyspnea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 19
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 11
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 17
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 13
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 21
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 16
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 7
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Myalgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 10
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 4
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 33
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 32
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 11
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Limb Edema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 21
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 7
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fever",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Insomnia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 15
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 20
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dizziness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 11
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hot Flashes",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 22
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 18
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Creatinine increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypocalcemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Neutrophil Count Decreased",
"notes": "Absolute Neutrophil Count - low (Verbatim Term)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Infection with unknown Absolute Neutrophil Count",
"notes": "Verbatim Term",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Chills",
"notes": "Verbatim Term - Rigors/chills",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Creatinine-Low",
"notes": "Verbatim Term",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Total Bilirubin Low",
"notes": "Verbatim Term",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Alopecia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Blurred Vision",
"notes": "Verbatim Terms: Blurred Vision, Vision Changes",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 5
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Chronic Kidney Disease",
"notes": "Verbatim Terms: Chronic Kidney Disease, Chronic Renal Disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dry Eye",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dry Mouth",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dry Skin",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dysgeusia",
"notes": "Verbatim Terms: Dysgeusia, Taste Changes",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Epistaxis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fall",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Flu Like Symptoms",
"notes": "Verbatim Terms: Flu Like Symptoms, Flu Symptoms, Flu Like Feeling",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypertension",
"notes": "Verbatim Terms: Hypertension, Hypertension-transient, High Blood Pressure",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 12
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 8
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Malaise",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Mucositis Oral",
"notes": "Verbatim Terms: Mouth Sore, Mucositis Oral, Mucositis, Mucosal Infection (System Organ Class: Infections and Infestations)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 6
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Numbness - fingers",
"notes": "General finger/hand numbness due to either Reynaud's syndrome or carpal tunnel",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rash (General, not otherwise specified)",
"notes": "Verbatim Terms: Rash Acneiform, Rash Maculo-papular, Purpura, Perioral Swelling, Skin Hyperpigmentation, Skin Redness, Shingles, Papulopustular Rash (Infections and Infestations - System Organ Class)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 13
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pressure - left pubic area",
"notes": "Verbatim Term",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Weight Loss",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 2
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 5
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Laryngeal Inflammation",
"notes": "Verbatim Terms: Laryngeal Inflammation, Sore Throat",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 5
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Toothache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Eye Disorders (not otherwise specified)",
"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)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Urinary Disorders (General)",
"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)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 6
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Reproductive system and breast disorders (General)",
"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",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Upper Respiratory Disorders (General)",
"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)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 13
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 8
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lower Respiratory Disorders (General, not otherwise specified)",
"notes": "Verbatim Terms: Pneumonitis, Asthma, Bronchospasm, Hemoptysis, Bronchial Infection (System Organ Class: Infections and Infestations), Pleural Infection (System Organ Class: Infections and Infestations)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Ear Disorders (General)",
"notes": "Verbatim Terms: Ear Pain, Ear Fullness/Pressure, Tinnitus, Otitis Media (System Organ Class: Infections and Infestations)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin Infections (General)",
"notes": "Verbatim Terms: Skin Infection, Skin Infection (Viral), Skin Infection (insect bite), Cellulitis, Cellulitis around pleurex site",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Infections (General), not otherwise specified",
"notes": "Verbatim Terms: Infection, Infection localized (big toe), Infection (other), Lip Infection, Nail Infection, Soft Tissue Infection, Herpes",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Musculoskeletal Pain Disorders (not otherwise specified)",
"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",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 10
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 10
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 7
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Sinus Tachycardia",
"notes": "Verbatim Terms: Sinus Tachycardia, Rapid Heartbeat",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Carcinomas",
"notes": "Verbatim Terms: Basal Cell Carcinoma, Squamous Cell Carcinoma",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hemoglobin - Low",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 24
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 35
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 15
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "White Blood Cells Decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 19
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 24
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 12
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Platelet Count Decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 17
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
}
],
"seriousEvents": [
{
"term": "Cardiac Arrest",
"notes": "CTCAE Grade 5, unrelated to study drug",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nausea",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vomiting",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyponatremia",
"notes": "CTCAE Grade 4",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypotension",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyperglycemia",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cardiac Disorder (Unspecified)",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dehydration",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pleural Effusion",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Spinal Fracture",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Endometrial cancer",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hip Fracture",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Number of Participants With Progression Free Survival (PFS) at 12 Months",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "OG000"
},
{
"value": "57",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Fulvestrant",
"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": "OG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "16",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "At 12 months",
"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",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED"
},
{
"type": "PRIMARY",
"title": "Number of Participants With Progression Free Survival (PFS) at 6 Months",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "OG000"
},
{
"value": "57",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Fulvestrant",
"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": "OG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "16",
"groupId": "OG000"
},
{
"value": "22",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "At 6 months",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Clinical Benefit Rate (CBR) of Adding Bortezomib to Fulvestrant in Arm C",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "27",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm C: Crossover From Arm A at Progression to Fulvestrant + Bortezomib",
"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."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "OG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "Up to 24 weeks",
"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.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "# of participants randomized to Arm A (Fulvestrant alone) who crossed over to fulvestrant plus bortezomib at progression (Arm C) and had clinical benefit."
},
{
"type": "SECONDARY",
"title": "Number of Participants Who Survived Until Study End (up to 7 Years)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "OG000"
},
{
"value": "57",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Fulvestrant Alone",
"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": "OG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "39",
"groupId": "OG000"
},
{
"value": "42",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "From first treatment day until study end, assessed up to 7 years",
"description": "Tabulation of the number of participants who survived from the date of first treatment until study end (up to 7 years).",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Progression Free Survival at 24 Weeks (Arm C)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "27",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm C: Crossover From Arm A at Progression to 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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "OG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "At 24 weeks",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Frequency of Most Common Toxicities",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "OG000"
},
{
"value": "57",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Fulvestrant",
"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": "OG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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>"
}
],
"classes": [
{
"title": "Hemoglobin-Low",
"categories": [
{
"measurements": [
{
"value": "41",
"groupId": "OG000"
},
{
"value": "61",
"groupId": "OG001"
}
]
}
]
},
{
"title": "White Blood Cell-Low",
"categories": [
{
"measurements": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "42",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Hyperglycemia/Glucose-High",
"categories": [
{
"measurements": [
{
"value": "44",
"groupId": "OG000"
},
{
"value": "51",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Hypoglycemia/Glucose-Low",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "SGOT (AST-High)",
"categories": [
{
"measurements": [
{
"value": "25",
"groupId": "OG000"
},
{
"value": "32",
"groupId": "OG001"
}
]
}
]
},
{
"title": "SGPT (ALT-High)",
"categories": [
{
"measurements": [
{
"value": "14",
"groupId": "OG000"
},
{
"value": "21",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Neutrophil Count Decreased/ANC-low",
"categories": [
{
"measurements": [
{
"value": "10",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Platelet Count Decreased/Platelets-Low",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "30",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Hypocalcemia/Calcium-Low",
"categories": [
{
"measurements": [
{
"value": "10",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Hyponatremia/Sodium-Low",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Nausea",
"categories": [
{
"measurements": [
{
"value": "29",
"groupId": "OG000"
},
{
"value": "63",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Vomiting",
"categories": [
{
"measurements": [
{
"value": "14",
"groupId": "OG000"
},
{
"value": "32",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Diarrhea",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "47",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Constipation",
"categories": [
{
"measurements": [
{
"value": "34",
"groupId": "OG000"
},
{
"value": "46",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Heartburn/Dyspepsia",
"categories": [
{
"measurements": [
{
"value": "10",
"groupId": "OG000"
},
{
"value": "18",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Anorexia",
"categories": [
{
"measurements": [
{
"value": "15",
"groupId": "OG000"
},
{
"value": "23",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Headache",
"categories": [
{
"measurements": [
{
"value": "12",
"groupId": "OG000"
},
{
"value": "25",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pain (general)",
"categories": [
{
"measurements": [
{
"value": "59",
"groupId": "OG000"
},
{
"value": "54",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Peripheral Neuropathy (Motor, Pain, Sensory)",
"categories": [
{
"measurements": [
{
"value": "31",
"groupId": "OG000"
},
{
"value": "49",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Injection Site Reaction",
"categories": [
{
"measurements": [
{
"value": "24",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Dyspnea",
"categories": [
{
"measurements": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "19",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Cough",
"categories": [
{
"measurements": [
{
"value": "29",
"groupId": "OG000"
},
{
"value": "23",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Fatigue",
"categories": [
{
"measurements": [
{
"value": "56",
"groupId": "OG000"
},
{
"value": "56",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Limb Edema",
"categories": [
{
"measurements": [
{
"value": "19",
"groupId": "OG000"
},
{
"value": "37",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Insomnia",
"categories": [
{
"measurements": [
{
"value": "25",
"groupId": "OG000"
},
{
"value": "35",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Hot Flashes",
"categories": [
{
"measurements": [
{
"value": "37",
"groupId": "OG000"
},
{
"value": "32",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Dizziness",
"categories": [
{
"measurements": [
{
"value": "7",
"groupId": "OG000"
},
{
"value": "19",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Arthralgia",
"categories": [
{
"measurements": [
{
"value": "36",
"groupId": "OG000"
},
{
"value": "28",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Myalgia",
"categories": [
{
"measurements": [
{
"value": "10",
"groupId": "OG000"
},
{
"value": "18",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Anxiety",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "19",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Fever",
"categories": [
{
"measurements": [
{
"value": "15",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pruritis",
"categories": [
{
"measurements": [
{
"value": "7",
"groupId": "OG000"
},
{
"value": "16",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Rash/Desquamation",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "11",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Depression",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "16",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Anemia",
"categories": [
{
"measurements": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "42",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Dry Eye",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Hypertension",
"categories": [
{
"measurements": [
{
"value": "12",
"groupId": "OG000"
},
{
"value": "21",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Rash (General)",
"categories": [
{
"measurements": [
{
"value": "7",
"groupId": "OG000"
},
{
"value": "23",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Eye Disorders (not otherwise specified)",
"categories": [
{
"measurements": [
{
"value": "7",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Urinary Disorders (General)",
"categories": [
{
"measurements": [
{
"value": "15",
"groupId": "OG000"
},
{
"value": "11",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Thrombocytopenia",
"categories": [
{
"measurements": [
{
"value": "41",
"groupId": "OG000"
},
{
"value": "61",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Neutropenia",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "30",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Upper Respiratory Disorders (General)",
"categories": [
{
"measurements": [
{
"value": "12",
"groupId": "OG000"
},
{
"value": "23",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Musculoskeletal Pain Disorders (not otherwise specified)",
"categories": [
{
"measurements": [
{
"value": "17",
"groupId": "OG000"
},
{
"value": "18",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Mucositis Oral",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "11",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "Up to 7 years",
"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.",
"unitOfMeasure": "percentage of participants",
"reportingStatus": "POSTED"
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Arm A: Fulvestrant Alone",
"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": "FG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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": "FG002",
"title": "Arm C: Crossover From Arm A at Progression to 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>"
}
],
"periods": [
{
"title": "Randomized Phase",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "59"
},
{
"groupId": "FG001",
"numSubjects": "59"
},
{
"groupId": "FG002",
"numSubjects": "0"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "59"
},
{
"groupId": "FG001",
"numSubjects": "57"
},
{
"groupId": "FG002",
"numSubjects": "0"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "2"
},
{
"groupId": "FG002",
"numSubjects": "0"
}
]
}
]
},
{
"title": "Crossover Phase",
"milestones": [
{
"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": "27"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
},
{
"groupId": "FG002",
"numSubjects": "0"
}
]
}
]
}
],
"recruitmentDetails": "118 patients were enrolled from 17 institutions between May 2010 and October 2013",
"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."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "57",
"groupId": "BG001"
},
{
"value": "116",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Arm A: Fulvestrant",
"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": "BG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "57",
"groupId": "BG001"
},
{
"value": "116",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "57",
"groupId": "BG000",
"lowerLimit": "31",
"upperLimit": "83"
},
{
"value": "59",
"groupId": "BG001",
"lowerLimit": "31",
"upperLimit": "80"
},
{
"value": "57",
"groupId": "BG002",
"lowerLimit": "31",
"upperLimit": "80"
}
]
}
]
}
],
"paramType": "MEDIAN",
"unitOfMeasure": "years",
"dispersionType": "FULL_RANGE"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "57",
"groupId": "BG001"
},
{
"value": "116",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "57",
"groupId": "BG001"
},
{
"value": "116",
"groupId": "BG002"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race and Ethnicity Not Collected",
"classes": [
{
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants",
"populationDescription": "Race and Ethnicity were not collected from any participant."
},
{
"title": "Region of Enrollment",
"classes": [
{
"title": "United States",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "57",
"groupId": "BG001"
},
{
"value": "116",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "57",
"groupId": "BG001"
},
{
"value": "116",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
}
]
}
} /protocolSection/statusModule/overallStatus ACTIVE_NOT_RECRUITING
COMPLETED
[
{
"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": {
"moreInfoModule": {
"pointOfContact": {
"email": "joseph.sparano@mssm.edu",
"phone": "212-241-3300",
"title": "Joseph Sparano, MD",
"organization": "Icahn School of Medicine at Mount Sinai"
},
"certainAgreement": {
"restrictionType": "LTE60",
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
},
"adverseEventsModule": {
"timeFrame": "Up to 7 years",
"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": [
{
"id": "EG000",
"title": "Arm A: Fulvestrant Alone",
"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>",
"otherNumAtRisk": 59,
"deathsNumAtRisk": 59,
"otherNumAffected": 59,
"seriousNumAtRisk": 59,
"deathsNumAffected": 11,
"seriousNumAffected": 9
},
{
"id": "EG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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>",
"otherNumAtRisk": 57,
"deathsNumAtRisk": 57,
"otherNumAffected": 57,
"seriousNumAtRisk": 57,
"deathsNumAffected": 15,
"seriousNumAffected": 6
},
{
"id": "EG002",
"title": "Arm C: Crossover From Arm A at Progression to Fulvestrant + Bortezomib",
"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>",
"otherNumAtRisk": 27,
"deathsNumAtRisk": 27,
"otherNumAffected": 27,
"seriousNumAtRisk": 27,
"deathsNumAffected": 9,
"seriousNumAffected": 5
}
],
"otherEvents": [
{
"term": "Anxiety",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 11
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 4
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Depression",
"notes": "Verbatim Terms: Depression, Seasonal Depression",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 9
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 5
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Anemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 19
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 24
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 12
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Neutropenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 17
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Thrombocytopenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 24
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 35
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 15
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyperglycemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 25
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 29
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 12
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypoglycemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "SGOT_AST-High",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 15
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 18
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "SGPT_ALT-High",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 12
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 5
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyponatremia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 6
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 16
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 34
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 12
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 17
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Diarrhea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 27
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 14
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 20
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 26
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 11
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Heartburn/Dyspepsia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 10
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Anorexia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 13
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 4
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 14
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 7
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 35
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 31
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 10
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Peripheral Neuropathy",
"notes": "Verbatim Terms: Neuropathy-Pain; Neuropathy-Motor; Neuropathy-Sensory",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 18
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 28
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 8
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rash/Desquamation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 6
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Injection Site Reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 14
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 4
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pruritis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 9
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dyspnea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 19
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 11
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 17
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 13
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 21
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 16
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 7
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Myalgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 10
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 4
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 33
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 32
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 11
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Limb Edema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 21
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 7
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fever",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Insomnia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 15
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 20
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dizziness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 11
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hot Flashes",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 22
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 18
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Creatinine increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypocalcemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Neutrophil Count Decreased",
"notes": "Absolute Neutrophil Count - low (Verbatim Term)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Infection with unknown Absolute Neutrophil Count",
"notes": "Verbatim Term",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Chills",
"notes": "Verbatim Term - Rigors/chills",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Creatinine-Low",
"notes": "Verbatim Term",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Total Bilirubin Low",
"notes": "Verbatim Term",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Alopecia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Blurred Vision",
"notes": "Verbatim Terms: Blurred Vision, Vision Changes",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 5
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Chronic Kidney Disease",
"notes": "Verbatim Terms: Chronic Kidney Disease, Chronic Renal Disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dry Eye",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dry Mouth",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dry Skin",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dysgeusia",
"notes": "Verbatim Terms: Dysgeusia, Taste Changes",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Epistaxis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fall",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Flu Like Symptoms",
"notes": "Verbatim Terms: Flu Like Symptoms, Flu Symptoms, Flu Like Feeling",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypertension",
"notes": "Verbatim Terms: Hypertension, Hypertension-transient, High Blood Pressure",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 12
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 8
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Malaise",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Mucositis Oral",
"notes": "Verbatim Terms: Mouth Sore, Mucositis Oral, Mucositis, Mucosal Infection (System Organ Class: Infections and Infestations)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 6
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Numbness - fingers",
"notes": "General finger/hand numbness due to either Reynaud's syndrome or carpal tunnel",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rash (General, not otherwise specified)",
"notes": "Verbatim Terms: Rash Acneiform, Rash Maculo-papular, Purpura, Perioral Swelling, Skin Hyperpigmentation, Skin Redness, Shingles, Papulopustular Rash (Infections and Infestations - System Organ Class)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 13
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pressure - left pubic area",
"notes": "Verbatim Term",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Weight Loss",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 2
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 5
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Laryngeal Inflammation",
"notes": "Verbatim Terms: Laryngeal Inflammation, Sore Throat",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 5
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Toothache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Eye Disorders (not otherwise specified)",
"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)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Urinary Disorders (General)",
"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)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 6
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Reproductive system and breast disorders (General)",
"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",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Upper Respiratory Disorders (General)",
"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)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 13
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 8
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lower Respiratory Disorders (General, not otherwise specified)",
"notes": "Verbatim Terms: Pneumonitis, Asthma, Bronchospasm, Hemoptysis, Bronchial Infection (System Organ Class: Infections and Infestations), Pleural Infection (System Organ Class: Infections and Infestations)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Ear Disorders (General)",
"notes": "Verbatim Terms: Ear Pain, Ear Fullness/Pressure, Tinnitus, Otitis Media (System Organ Class: Infections and Infestations)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin Infections (General)",
"notes": "Verbatim Terms: Skin Infection, Skin Infection (Viral), Skin Infection (insect bite), Cellulitis, Cellulitis around pleurex site",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 3
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Infections (General), not otherwise specified",
"notes": "Verbatim Terms: Infection, Infection localized (big toe), Infection (other), Lip Infection, Nail Infection, Soft Tissue Infection, Herpes",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Musculoskeletal Pain Disorders (not otherwise specified)",
"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",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 10
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 10
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 7
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Sinus Tachycardia",
"notes": "Verbatim Terms: Sinus Tachycardia, Rapid Heartbeat",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 2
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Carcinomas",
"notes": "Verbatim Terms: Basal Cell Carcinoma, Squamous Cell Carcinoma",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 0
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hemoglobin - Low",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 24
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 35
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 15
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "White Blood Cells Decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 19
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 24
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 12
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Platelet Count Decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numAffected": 17
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numAffected": 6
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
}
],
"seriousEvents": [
{
"term": "Cardiac Arrest",
"notes": "CTCAE Grade 5, unrelated to study drug",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nausea",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vomiting",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyponatremia",
"notes": "CTCAE Grade 4",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypotension",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyperglycemia",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cardiac Disorder (Unspecified)",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dehydration",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pleural Effusion",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Spinal Fracture",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Endometrial cancer",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hip Fracture",
"notes": "CTCAE Grade 3",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 59,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 57,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 27,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Number of Participants With Progression Free Survival (PFS) at 12 Months",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "OG000"
},
{
"value": "57",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Fulvestrant",
"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": "OG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "16",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "At 12 months",
"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",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED"
},
{
"type": "PRIMARY",
"title": "Number of Participants With Progression Free Survival (PFS) at 6 Months",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "OG000"
},
{
"value": "57",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Fulvestrant",
"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": "OG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "16",
"groupId": "OG000"
},
{
"value": "22",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "At 6 months",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Clinical Benefit Rate (CBR) of Adding Bortezomib to Fulvestrant in Arm C",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "27",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm C: Crossover From Arm A at Progression to Fulvestrant + Bortezomib",
"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."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "OG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "Up to 24 weeks",
"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.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "# of participants randomized to Arm A (Fulvestrant alone) who crossed over to fulvestrant plus bortezomib at progression (Arm C) and had clinical benefit."
},
{
"type": "SECONDARY",
"title": "Number of Participants Who Survived Until Study End (up to 7 Years)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "OG000"
},
{
"value": "57",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Fulvestrant Alone",
"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": "OG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "39",
"groupId": "OG000"
},
{
"value": "42",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "From first treatment day until study end, assessed up to 7 years",
"description": "Tabulation of the number of participants who survived from the date of first treatment until study end (up to 7 years).",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Progression Free Survival at 24 Weeks (Arm C)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "27",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm C: Crossover From Arm A at Progression to 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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "OG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "At 24 weeks",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Frequency of Most Common Toxicities",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "OG000"
},
{
"value": "57",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Fulvestrant",
"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": "OG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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>"
}
],
"classes": [
{
"title": "Hemoglobin-Low",
"categories": [
{
"measurements": [
{
"value": "41",
"groupId": "OG000"
},
{
"value": "61",
"groupId": "OG001"
}
]
}
]
},
{
"title": "White Blood Cell-Low",
"categories": [
{
"measurements": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "42",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Hyperglycemia/Glucose-High",
"categories": [
{
"measurements": [
{
"value": "44",
"groupId": "OG000"
},
{
"value": "51",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Hypoglycemia/Glucose-Low",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "SGOT (AST-High)",
"categories": [
{
"measurements": [
{
"value": "25",
"groupId": "OG000"
},
{
"value": "32",
"groupId": "OG001"
}
]
}
]
},
{
"title": "SGPT (ALT-High)",
"categories": [
{
"measurements": [
{
"value": "14",
"groupId": "OG000"
},
{
"value": "21",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Neutrophil Count Decreased/ANC-low",
"categories": [
{
"measurements": [
{
"value": "10",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Platelet Count Decreased/Platelets-Low",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "30",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Hypocalcemia/Calcium-Low",
"categories": [
{
"measurements": [
{
"value": "10",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Hyponatremia/Sodium-Low",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Nausea",
"categories": [
{
"measurements": [
{
"value": "29",
"groupId": "OG000"
},
{
"value": "63",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Vomiting",
"categories": [
{
"measurements": [
{
"value": "14",
"groupId": "OG000"
},
{
"value": "32",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Diarrhea",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "47",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Constipation",
"categories": [
{
"measurements": [
{
"value": "34",
"groupId": "OG000"
},
{
"value": "46",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Heartburn/Dyspepsia",
"categories": [
{
"measurements": [
{
"value": "10",
"groupId": "OG000"
},
{
"value": "18",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Anorexia",
"categories": [
{
"measurements": [
{
"value": "15",
"groupId": "OG000"
},
{
"value": "23",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Headache",
"categories": [
{
"measurements": [
{
"value": "12",
"groupId": "OG000"
},
{
"value": "25",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pain (general)",
"categories": [
{
"measurements": [
{
"value": "59",
"groupId": "OG000"
},
{
"value": "54",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Peripheral Neuropathy (Motor, Pain, Sensory)",
"categories": [
{
"measurements": [
{
"value": "31",
"groupId": "OG000"
},
{
"value": "49",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Injection Site Reaction",
"categories": [
{
"measurements": [
{
"value": "24",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Dyspnea",
"categories": [
{
"measurements": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "19",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Cough",
"categories": [
{
"measurements": [
{
"value": "29",
"groupId": "OG000"
},
{
"value": "23",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Fatigue",
"categories": [
{
"measurements": [
{
"value": "56",
"groupId": "OG000"
},
{
"value": "56",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Limb Edema",
"categories": [
{
"measurements": [
{
"value": "19",
"groupId": "OG000"
},
{
"value": "37",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Insomnia",
"categories": [
{
"measurements": [
{
"value": "25",
"groupId": "OG000"
},
{
"value": "35",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Hot Flashes",
"categories": [
{
"measurements": [
{
"value": "37",
"groupId": "OG000"
},
{
"value": "32",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Dizziness",
"categories": [
{
"measurements": [
{
"value": "7",
"groupId": "OG000"
},
{
"value": "19",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Arthralgia",
"categories": [
{
"measurements": [
{
"value": "36",
"groupId": "OG000"
},
{
"value": "28",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Myalgia",
"categories": [
{
"measurements": [
{
"value": "10",
"groupId": "OG000"
},
{
"value": "18",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Anxiety",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "19",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Fever",
"categories": [
{
"measurements": [
{
"value": "15",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pruritis",
"categories": [
{
"measurements": [
{
"value": "7",
"groupId": "OG000"
},
{
"value": "16",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Rash/Desquamation",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "11",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Depression",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "16",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Anemia",
"categories": [
{
"measurements": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "42",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Dry Eye",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Hypertension",
"categories": [
{
"measurements": [
{
"value": "12",
"groupId": "OG000"
},
{
"value": "21",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Rash (General)",
"categories": [
{
"measurements": [
{
"value": "7",
"groupId": "OG000"
},
{
"value": "23",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Eye Disorders (not otherwise specified)",
"categories": [
{
"measurements": [
{
"value": "7",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Urinary Disorders (General)",
"categories": [
{
"measurements": [
{
"value": "15",
"groupId": "OG000"
},
{
"value": "11",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Thrombocytopenia",
"categories": [
{
"measurements": [
{
"value": "41",
"groupId": "OG000"
},
{
"value": "61",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Neutropenia",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "30",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Upper Respiratory Disorders (General)",
"categories": [
{
"measurements": [
{
"value": "12",
"groupId": "OG000"
},
{
"value": "23",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Musculoskeletal Pain Disorders (not otherwise specified)",
"categories": [
{
"measurements": [
{
"value": "17",
"groupId": "OG000"
},
{
"value": "18",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Mucositis Oral",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "11",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "Up to 7 years",
"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.",
"unitOfMeasure": "percentage of participants",
"reportingStatus": "POSTED"
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Arm A: Fulvestrant Alone",
"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": "FG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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": "FG002",
"title": "Arm C: Crossover From Arm A at Progression to 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>"
}
],
"periods": [
{
"title": "Randomized Phase",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "59"
},
{
"groupId": "FG001",
"numSubjects": "59"
},
{
"groupId": "FG002",
"numSubjects": "0"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "59"
},
{
"groupId": "FG001",
"numSubjects": "57"
},
{
"groupId": "FG002",
"numSubjects": "0"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "2"
},
{
"groupId": "FG002",
"numSubjects": "0"
}
]
}
]
},
{
"title": "Crossover Phase",
"milestones": [
{
"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": "27"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
},
{
"groupId": "FG002",
"numSubjects": "0"
}
]
}
]
}
],
"recruitmentDetails": "118 patients were enrolled from 17 institutions between May 2010 and October 2013",
"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."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "57",
"groupId": "BG001"
},
{
"value": "116",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Arm A: Fulvestrant",
"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": "BG001",
"title": "Arm B: Fulvestrant + Bortezomib",
"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": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "57",
"groupId": "BG001"
},
{
"value": "116",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "57",
"groupId": "BG000",
"lowerLimit": "31",
"upperLimit": "83"
},
{
"value": "59",
"groupId": "BG001",
"lowerLimit": "31",
"upperLimit": "80"
},
{
"value": "57",
"groupId": "BG002",
"lowerLimit": "31",
"upperLimit": "80"
}
]
}
]
}
],
"paramType": "MEDIAN",
"unitOfMeasure": "years",
"dispersionType": "FULL_RANGE"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "57",
"groupId": "BG001"
},
{
"value": "116",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "57",
"groupId": "BG001"
},
{
"value": "116",
"groupId": "BG002"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race and Ethnicity Not Collected",
"classes": [
{
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants",
"populationDescription": "Race and Ethnicity were not collected from any participant."
},
{
"title": "Region of Enrollment",
"classes": [
{
"title": "United States",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "57",
"groupId": "BG001"
},
{
"value": "116",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "57",
"groupId": "BG001"
},
{
"value": "116",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
}
]
}
}
}
]