NCT01730833
Version 25 to 26 · City of Hope Medical Center
Patch inspector
Manual review pending.
enrollment_count_changeenrollment_type_change [
{
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"signal": "timeline_actualized_earlier",
"category": "timeline_actualized_earlier",
"new_type": "ACTUAL",
"old_type": "ESTIMATED",
"severity": "low",
"direction": "earlier",
"new_value": "2021-01-12",
"old_value": "2023-10-25",
"delta_days": 1016,
"date_struct": "primaryCompletionDateStruct",
"new_precision": "day",
"old_precision": "day"
},
{
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/1/description",
"/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/2",
"/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/2"
],
"signal": "results_reconciliation_outcome_suppression",
"category": "results_reconciliation",
"severity": "low"
}
] c14a90f0d19d83059e60de30678fa907e948aa01d5f8b1a5bcc7f19d3dde3b2f/protocolSection/outcomesModule/primaryOutcomes/0/measure primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Progression free survival
Progression Free Survival (MBC Cohort)
/protocolSection/outcomesModule/primaryOutcomes/0/description primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Estimated by the Kaplan-Meier method. The corresponding median survival time (with 90% confidence limits) will be determined.
Estimated using the product-limit method of Kaplan and Meier. From time of initial treatment until disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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. Time from initiation of treatment until objective disease progression, assessed up to 5 years
assessed up to 5 years
/protocolSection/outcomesModule/primaryOutcomes/1/measure primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. PFS (MBC patients)
Five Year Disease-free Survival (LABC Cohort)
/protocolSection/outcomesModule/primaryOutcomes/1/description primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Estimated by the Kaplan-Meier method. The corresponding median survival time (with 90% confidence limits) will be determined.
Estimated using the method of Kaplan-Meier. Disease-free survival is defined as the time from Initial treatment to recurrence of tumor or death
/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Time from initiation of treatment until objective disease progression, assessed up to 5 years
assessed up to 5 years
/protocolSection/outcomesModule/primaryOutcomes/2 primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. {
"measure": "PFS (LABC patients)",
"timeFrame": "Time from initiation of treatment until objective disease progression, assessed up to 5 years",
"description": "Estimated by the Kaplan-Meier method.\nThe corresponding median survival time (with 90% confidence limits) will be determined."
} /protocolSection/designModule/enrollmentInfo/count enrollment_count_change Enrollment count changes can signal scope or feasibility shifts. 65
63
/protocolSection/designModule/enrollmentInfo/type enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority. ESTIMATED
ACTUAL
/protocolSection/outcomesModule/secondaryOutcomes/0/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Overall survival
Overall Response (MBC Cohort)
/protocolSection/outcomesModule/secondaryOutcomes/0/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Estimated by the Kaplan-Meier method. Corresponding survival times with 90% confidence limits will be determined.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. From the initial date of treatment to the recorded date of death, assessed up to 5 years
Up to 5 years
/protocolSection/outcomesModule/secondaryOutcomes/1/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Number of patients experiencing serious adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Five Year Overall Survival
/protocolSection/outcomesModule/secondaryOutcomes/1/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Characterized by type of AE and grade, and by the time of onset in relation to the first day of therapy for each course. Attribution to SAEs to treatment (unrelated, unlikely, possible, probable, or definite) will also be reported. The cumulative percentage of patients experiencing treatment related SAEs and its relationship to treatment duration will be reported.
Estimated by the Kaplan-Meier method. From the initial date of treatment to date of death from any cause.
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Up to 30 days post-treatment
Assessed up to 5 years
/protocolSection/outcomesModule/secondaryOutcomes/2 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Objective response rate (RECIST 1.1) (MBC patients)",
"timeFrame": "Up to 5 years"
} /protocolSection/outcomesModule/secondaryOutcomes/2 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Clinical benefit rate, defined as the rate of complete response (CR) plus partial response (PR) plus stable disease (SD) (MBC patients)",
"timeFrame": "Up to 5 years"
} /protocolSection/outcomesModule/secondaryOutcomes/2 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Complete pathologic response, analyzed using residual cancer burden score (LABC patients)",
"timeFrame": "Up to 18 weeks (time of definitive surgery)"
} /protocolSection/outcomesModule/secondaryOutcomes/2 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Relapse-free survival (LABC patients)",
"timeFrame": "Up to 5 years",
"description": "Estimated by the Kaplan-Meier method.\nThe corresponding median survival time (with 90% confidence limits) will be determined."
} /protocolSection/statusModule/primaryCompletionDateStruct/date primary_completion_timeline_change Primary completion date changes are operational timeline signals. 2023-10-25
2021-01-12
/protocolSection/statusModule/primaryCompletionDateStruct/type primary_completion_timeline_change Primary completion date changes are operational timeline signals. ESTIMATED
ACTUAL
/protocolSection/statusModule/statusVerifiedDate 2022-03
2023-06
/protocolSection/statusModule/lastUpdateSubmitDate 2022-03-17
2023-06-26
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2022-03-18
2023-06-28
/protocolSection/statusModule/resultsFirstSubmitDate 2023-03-10
/protocolSection/statusModule/resultsFirstSubmitQcDate 2023-06-26
/protocolSection/statusModule/resultsFirstPostDateStruct {
"date": "2023-06-28",
"type": "ACTUAL"
} /annotationSection {
"annotationModule": {
"unpostedAnnotation": {
"unpostedEvents": [
{
"date": "2023-03-10",
"type": "RELEASE"
},
{
"date": "2023-04-05",
"type": "RESET"
},
{
"date": "2023-04-05",
"type": "RELEASE"
},
{
"date": "2023-04-26",
"type": "RESET"
}
],
"unpostedResponsibleParty": "City of Hope Medical Center"
}
}
} /hasResults false
true
/resultsSection {
"moreInfoModule": {
"pointOfContact": {
"email": "pfrankel@coh.org",
"phone": "626-218-5265",
"title": "Paul Frankel, Ph.D.",
"organization": "City of Hope"
},
"certainAgreement": {
"piSponsorEmployee": true
}
},
"adverseEventsModule": {
"timeFrame": "Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.",
"description": ""Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.",
"eventGroups": [
{
"id": "EG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>",
"otherNumAtRisk": 18,
"deathsNumAtRisk": 18,
"otherNumAffected": 18,
"seriousNumAtRisk": 18,
"deathsNumAffected": 8,
"seriousNumAffected": 3
},
{
"id": "EG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>",
"otherNumAtRisk": 45,
"deathsNumAtRisk": 45,
"otherNumAffected": 45,
"seriousNumAtRisk": 45,
"deathsNumAffected": 2,
"seriousNumAffected": 4
}
],
"otherEvents": [
{
"term": "Anemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 162,
"numAffected": 16
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 172,
"numAffected": 40
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Leukocytosis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 2
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cardiac disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Chest pain - cardiac",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Palpitations",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 2
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Sinus bradycardia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Sinus tachycardia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 21,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 22,
"numAffected": 7
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Tricuspid valve disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Ear and labyrinth disorders - Other, spe",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 1
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Ear pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hearing impaired",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Tinnitus",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vertigo",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vestibular disorder",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Blurred vision",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 12,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dry eye",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 3
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Eye disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 6,
"numAffected": 4
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Eye pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Floaters",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Watering eyes",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 3
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Abdominal distension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Abdominal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 11,
"numAffected": 7
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Bloating",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 12,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 34,
"numAffected": 16
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Diarrhea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 29,
"numAffected": 10
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 86,
"numAffected": 31
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dry mouth",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dyspepsia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 4
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Esophageal ulcer",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Flatulence",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Gastritis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 20,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Gastroesophageal reflux disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 15,
"numAffected": 5
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Gastrointestinal disorders - Other, spec",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 8,
"numAffected": 6
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Gastrointestinal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hemorrhoidal hemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hemorrhoids",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 23,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 22,
"numAffected": 8
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Mucositis oral",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 14,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 14,
"numAffected": 8
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 24,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 68,
"numAffected": 28
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Oral dysesthesia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Oral pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rectal hemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rectal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Salivary duct inflammation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Stomach pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Toothache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 8,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 12,
"numAffected": 10
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Chills",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 7
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Edema face",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Edema limbs",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 62,
"numAffected": 10
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 39,
"numAffected": 17
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Facial pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 120,
"numAffected": 16
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 183,
"numAffected": 43
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fever",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 5
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Flu like symptoms",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Gait disturbance",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "General disorders and administration sit",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Infusion related reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 9,
"numAffected": 7
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Injection site reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Irritability",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Localized edema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Malaise",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Non-cardiac chest pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 10,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 11,
"numAffected": 6
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hepatobiliary disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Hepatobiliary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Allergic reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Immune system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Bladder infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Breast infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Eye infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lip infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nail infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 8,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 13,
"numAffected": 6
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Otitis externa",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Paronychia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 29,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 5
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rash pustular",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Sinusitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 2
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Tooth infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Upper respiratory infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 12,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 12,
"numAffected": 7
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Urinary tract infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 5
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vaginal infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Bruising",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 5,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fall",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fracture",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 4,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Seroma",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Wound dehiscence",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Alanine aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 27,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 79,
"numAffected": 22
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Alkaline phosphatase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 8,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 24,
"numAffected": 9
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Aspartate aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 44,
"numAffected": 10
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 62,
"numAffected": 16
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Blood bilirubin increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cholesterol high",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Creatinine increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lipase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lymphocyte count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 4
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lymphocyte count increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Neutrophil count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 29,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 26,
"numAffected": 13
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Platelet count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 4,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Serum amylase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Weight gain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 4,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Weight loss",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 10,
"numAffected": 3
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "White blood cell decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 108,
"numAffected": 14
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 80,
"numAffected": 27
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Anorexia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 10,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 17,
"numAffected": 7
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dehydration",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Glucose intolerance",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypercalcemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 9,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyperglycemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 8,
"numAffected": 3
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyperkalemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypernatremia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 14,
"numAffected": 7
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypertriglyceridemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 6,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypoalbuminemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 23,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 13,
"numAffected": 7
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypocalcemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 29,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 18,
"numAffected": 8
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypoglycemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 11,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypokalemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 15,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 26,
"numAffected": 12
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypomagnesemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyponatremia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 13,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 33,
"numAffected": 16
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypophosphatemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 16,
"numAffected": 8
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Metabolism and nutrition disorders - Oth",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Obesity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 11,
"numAffected": 5
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Arthritis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 6,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Back pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 12,
"numAffected": 7
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Bone pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 9,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 9,
"numAffected": 3
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Chest wall pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 20,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Flank pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Generalized muscle weakness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 2
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Muscle weakness lower limb",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Musculoskeletal and connective tissue di",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Myalgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 12,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 4
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Neck pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pain in extremity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 13,
"numAffected": 8
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Neoplasms benign, malignant and unspecif",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Tumor pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 13,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cognitive disturbance",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dizziness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 7,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dysgeusia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 7,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 31,
"numAffected": 13
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 18,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 8,
"numAffected": 7
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nervous system disorders - Other, specif",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Paresthesia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 4
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Peripheral sensory neuropathy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 104,
"numAffected": 15
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 150,
"numAffected": 36
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Spasticity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Anxiety",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 17,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 17,
"numAffected": 8
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Depression",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 8,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 11,
"numAffected": 4
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Insomnia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 16,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 22,
"numAffected": 8
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Psychiatric disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Restlessness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hematuria",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Proteinuria",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Urinary frequency",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Urinary incontinence",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Urinary tract pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Breast pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 10,
"numAffected": 5
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Irregular menstruation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 2
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Menorrhagia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 5,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Reproductive system and breast disorders",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vaginal dryness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Allergic rhinitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 18,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 3
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 16,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 18,
"numAffected": 10
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dyspnea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 12,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Epistaxis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 17,
"numAffected": 9
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hoarseness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nasal congestion",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 5,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 8,
"numAffected": 6
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Postnasal drip",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Productive cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Respiratory, thoracic and mediastinal di",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Sore throat",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 5,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 10,
"numAffected": 4
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Alopecia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 73,
"numAffected": 12
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 42,
"numAffected": 16
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dry skin",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 8,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 22,
"numAffected": 10
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Erythema multiforme",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nail discoloration",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 37,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 38,
"numAffected": 15
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nail loss",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 16,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 8,
"numAffected": 3
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nail ridging",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pain of skin",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 5,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 3
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Palmar-plantar erythrodysesthesia syndro",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Periorbital edema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Photosensitivity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pruritus",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 9,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 19,
"numAffected": 10
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rash acneiform",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 46,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 78,
"numAffected": 24
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rash maculo-papular",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 9,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 24,
"numAffected": 11
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin and subcutaneous tissue disorders -",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 30,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 30,
"numAffected": 13
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin hyperpigmentation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 43,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 34,
"numAffected": 12
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin hypopigmentation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 5,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin ulceration",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Urticaria",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hot flashes",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 21,
"numAffected": 6
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypertension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 122,
"numAffected": 14
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 148,
"numAffected": 29
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypotension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lymphedema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 7,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Thromboembolic event",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 4,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vascular disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
}
],
"seriousEvents": [
{
"term": "Atrial fibrillation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cardiac disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Blurred vision",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Edema limbs",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Catheter related infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Creatinine increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyponatremia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Metabolism and nutrition disorders - Oth",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dyspnea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Respiratory, thoracic and mediastinal di",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Thromboembolic event",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
}
],
"frequencyThreshold": "0"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Progression Free Survival (MBC Cohort)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "18",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "OG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "22.4",
"comment": "NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.",
"groupId": "OG000",
"lowerLimit": "7.1",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "assessed up to 5 years",
"description": "Estimated using the product-limit method of Kaplan and Meier.\nFrom time of initial treatment until disease progression or death.\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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": "Months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "PFS was not performed on the LABC cohort (neoadjuvant patients).\nA more relevant analysis, Disease-free survival is present elsewhere in these results."
},
{
"type": "PRIMARY",
"title": "Five Year Disease-free Survival (LABC Cohort)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "29",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "OG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "96.3",
"groupId": "OG001",
"lowerLimit": "76.5",
"upperLimit": "99.5"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "assessed up to 5 years",
"description": "Estimated using the method of Kaplan-Meier.\nDisease-free survival is defined as the time from Initial treatment to recurrence of tumor or death",
"unitOfMeasure": "percentage of participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Analysis population included LABC participants who achieved pathologic response (pCR).\nMore appropriate PFS analysis for MBC cohort is presented elsewhere in these results."
},
{
"type": "SECONDARY",
"title": "Overall Response (MBC Cohort)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "18",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "OG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "13",
"groupId": "OG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "Up to 5 years",
"description": "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Overall response is not appropriate in the neoadjuvant or LABC cohort."
},
{
"type": "SECONDARY",
"title": "Five Year Overall Survival",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "18",
"groupId": "OG000"
},
{
"value": "45",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "OG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "54.5",
"groupId": "OG000",
"lowerLimit": "8.6",
"upperLimit": "86.1"
},
{
"value": "94.1",
"groupId": "OG001",
"lowerLimit": "77.6",
"upperLimit": "98.5"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "Assessed up to 5 years",
"description": "Estimated by the Kaplan-Meier method.\nFrom the initial date of treatment to date of death from any cause.",
"unitOfMeasure": "percentage of participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED"
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "FG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "18"
},
{
"groupId": "FG001",
"numSubjects": "45"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "18"
},
{
"groupId": "FG001",
"numSubjects": "45"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
}
]
}
]
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "18",
"groupId": "BG000"
},
{
"value": "45",
"groupId": "BG001"
},
{
"value": "63",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "BG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "49",
"groupId": "BG000",
"lowerLimit": "31",
"upperLimit": "65"
},
{
"value": "56",
"groupId": "BG001",
"lowerLimit": "31",
"upperLimit": "78"
},
{
"value": "54",
"groupId": "BG002",
"lowerLimit": "31",
"upperLimit": "78"
}
]
}
]
}
],
"paramType": "MEDIAN",
"unitOfMeasure": "years",
"dispersionType": "FULL_RANGE"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "18",
"groupId": "BG000"
},
{
"value": "45",
"groupId": "BG001"
},
{
"value": "63",
"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/Ethnicity, Customized",
"classes": [
{
"title": "African American",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Asian",
"categories": [
{
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "7",
"groupId": "BG001"
},
{
"value": "9",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Hispanic",
"categories": [
{
"measurements": [
{
"value": "10",
"groupId": "BG000"
},
{
"value": "19",
"groupId": "BG001"
},
{
"value": "29",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Non-Hispanic White",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "BG000"
},
{
"value": "17",
"groupId": "BG001"
},
{
"value": "22",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Unknown",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Region of Enrollment",
"classes": [
{
"title": "United States",
"categories": [
{
"measurements": [
{
"value": "18",
"groupId": "BG000"
},
{
"value": "45",
"groupId": "BG001"
},
{
"value": "63",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
}
]
}
} /documentSection {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2017-07-27",
"size": 1340713,
"label": "Study Protocol and Statistical Analysis Plan",
"hasIcf": false,
"hasSap": true,
"filename": "Prot_SAP_000.pdf",
"typeAbbrev": "Prot_SAP",
"uploadDate": "2023-04-05T18:58",
"hasProtocol": true
}
]
}
} [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2023-06"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2021-01-12"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2023-06-26"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2023-06-28"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2023-03-10"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2023-06-26"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2023-06-28",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 63
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Progression Free Survival (MBC Cohort)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Estimated using the product-limit method of Kaplan and Meier.\nFrom time of initial treatment until disease progression or death.\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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": "assessed up to 5 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"value": "Five Year Disease-free Survival (LABC Cohort)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
"value": "Estimated using the method of Kaplan-Meier.\nDisease-free survival is defined as the time from Initial treatment to recurrence of tumor or death"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
"value": "assessed up to 5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Overall Response (MBC Cohort)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "Up to 5 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Five Year Overall Survival"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "Estimated by the Kaplan-Meier method.\nFrom the initial date of treatment to date of death from any cause."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "Assessed up to 5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2"
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "pfrankel@coh.org",
"phone": "626-218-5265",
"title": "Paul Frankel, Ph.D.",
"organization": "City of Hope"
},
"certainAgreement": {
"piSponsorEmployee": true
}
},
"adverseEventsModule": {
"timeFrame": "Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.",
"description": ""Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.",
"eventGroups": [
{
"id": "EG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>",
"otherNumAtRisk": 18,
"deathsNumAtRisk": 18,
"otherNumAffected": 18,
"seriousNumAtRisk": 18,
"deathsNumAffected": 8,
"seriousNumAffected": 3
},
{
"id": "EG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>",
"otherNumAtRisk": 45,
"deathsNumAtRisk": 45,
"otherNumAffected": 45,
"seriousNumAtRisk": 45,
"deathsNumAffected": 2,
"seriousNumAffected": 4
}
],
"otherEvents": [
{
"term": "Anemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 162,
"numAffected": 16
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 172,
"numAffected": 40
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Leukocytosis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 2
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cardiac disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Chest pain - cardiac",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Palpitations",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 2
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Sinus bradycardia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Sinus tachycardia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 21,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 22,
"numAffected": 7
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Tricuspid valve disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Ear and labyrinth disorders - Other, spe",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 1
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Ear pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hearing impaired",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Tinnitus",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vertigo",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vestibular disorder",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Blurred vision",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 12,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dry eye",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 3
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Eye disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 6,
"numAffected": 4
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Eye pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Floaters",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Watering eyes",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 3
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Abdominal distension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Abdominal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 11,
"numAffected": 7
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Bloating",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 12,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 34,
"numAffected": 16
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Diarrhea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 29,
"numAffected": 10
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 86,
"numAffected": 31
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dry mouth",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dyspepsia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 4
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Esophageal ulcer",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Flatulence",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Gastritis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 20,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Gastroesophageal reflux disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 15,
"numAffected": 5
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Gastrointestinal disorders - Other, spec",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 8,
"numAffected": 6
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Gastrointestinal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hemorrhoidal hemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hemorrhoids",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 23,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 22,
"numAffected": 8
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Mucositis oral",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 14,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 14,
"numAffected": 8
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 24,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 68,
"numAffected": 28
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Oral dysesthesia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Oral pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rectal hemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rectal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Salivary duct inflammation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Stomach pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Toothache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 8,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 12,
"numAffected": 10
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Chills",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 7
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Edema face",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Edema limbs",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 62,
"numAffected": 10
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 39,
"numAffected": 17
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Facial pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 120,
"numAffected": 16
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 183,
"numAffected": 43
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fever",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 5
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Flu like symptoms",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Gait disturbance",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "General disorders and administration sit",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Infusion related reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 9,
"numAffected": 7
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Injection site reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Irritability",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Localized edema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Malaise",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Non-cardiac chest pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 10,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 11,
"numAffected": 6
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hepatobiliary disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Hepatobiliary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Allergic reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Immune system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Bladder infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Breast infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Eye infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lip infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nail infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 8,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 13,
"numAffected": 6
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Otitis externa",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Paronychia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 29,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 5
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rash pustular",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Sinusitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 2
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Tooth infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Upper respiratory infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 12,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 12,
"numAffected": 7
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Urinary tract infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 5
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vaginal infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Bruising",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 5,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fall",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fracture",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 4,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Seroma",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Wound dehiscence",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Alanine aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 27,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 79,
"numAffected": 22
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Alkaline phosphatase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 8,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 24,
"numAffected": 9
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Aspartate aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 44,
"numAffected": 10
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 62,
"numAffected": 16
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Blood bilirubin increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cholesterol high",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Creatinine increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lipase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lymphocyte count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 4
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lymphocyte count increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Neutrophil count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 29,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 26,
"numAffected": 13
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Platelet count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 4,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Serum amylase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Weight gain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 4,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Weight loss",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 10,
"numAffected": 3
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "White blood cell decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 108,
"numAffected": 14
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 80,
"numAffected": 27
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Anorexia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 10,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 17,
"numAffected": 7
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dehydration",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Glucose intolerance",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypercalcemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 9,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyperglycemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 8,
"numAffected": 3
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyperkalemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypernatremia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 14,
"numAffected": 7
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypertriglyceridemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 6,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypoalbuminemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 23,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 13,
"numAffected": 7
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypocalcemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 29,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 18,
"numAffected": 8
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypoglycemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 11,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypokalemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 15,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 26,
"numAffected": 12
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypomagnesemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyponatremia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 13,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 33,
"numAffected": 16
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypophosphatemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 16,
"numAffected": 8
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Metabolism and nutrition disorders - Oth",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Obesity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 11,
"numAffected": 5
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Arthritis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 6,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Back pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 12,
"numAffected": 7
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Bone pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 9,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 9,
"numAffected": 3
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Chest wall pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 20,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Flank pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Generalized muscle weakness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 2
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Muscle weakness lower limb",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Musculoskeletal and connective tissue di",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Myalgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 12,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 4
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Neck pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pain in extremity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 13,
"numAffected": 8
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Neoplasms benign, malignant and unspecif",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Tumor pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 13,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cognitive disturbance",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dizziness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 7,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dysgeusia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 7,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 31,
"numAffected": 13
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 18,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 8,
"numAffected": 7
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nervous system disorders - Other, specif",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Paresthesia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 7,
"numAffected": 4
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Peripheral sensory neuropathy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 104,
"numAffected": 15
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 150,
"numAffected": 36
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Spasticity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Anxiety",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 17,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 17,
"numAffected": 8
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Depression",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 8,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 11,
"numAffected": 4
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Insomnia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 16,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 22,
"numAffected": 8
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Psychiatric disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Restlessness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hematuria",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Proteinuria",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Urinary frequency",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Urinary incontinence",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Urinary tract pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Breast pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 10,
"numAffected": 5
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Irregular menstruation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 2
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Menorrhagia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 5,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Reproductive system and breast disorders",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vaginal dryness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Allergic rhinitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 18,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 3
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 16,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 18,
"numAffected": 10
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dyspnea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 12,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Epistaxis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 17,
"numAffected": 9
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hoarseness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nasal congestion",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 5,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 8,
"numAffected": 6
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Postnasal drip",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Productive cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Respiratory, thoracic and mediastinal di",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Sore throat",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 5,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 10,
"numAffected": 4
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Alopecia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 73,
"numAffected": 12
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 42,
"numAffected": 16
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dry skin",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 8,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 22,
"numAffected": 10
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Erythema multiforme",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nail discoloration",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 37,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 38,
"numAffected": 15
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nail loss",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 16,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 8,
"numAffected": 3
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nail ridging",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pain of skin",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 5,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 3
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Palmar-plantar erythrodysesthesia syndro",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Periorbital edema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 5,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Photosensitivity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pruritus",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 9,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 19,
"numAffected": 10
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rash acneiform",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 46,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 78,
"numAffected": 24
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Rash maculo-papular",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 9,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 24,
"numAffected": 11
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin and subcutaneous tissue disorders -",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 30,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 30,
"numAffected": 13
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin hyperpigmentation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 43,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 34,
"numAffected": 12
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin hypopigmentation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 5,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin ulceration",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Urticaria",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hot flashes",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 21,
"numAffected": 6
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypertension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 122,
"numAffected": 14
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 148,
"numAffected": 29
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypotension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lymphedema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 7,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Thromboembolic event",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 4,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vascular disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
}
],
"seriousEvents": [
{
"term": "Atrial fibrillation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cardiac disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Blurred vision",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Edema limbs",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Catheter related infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Creatinine increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyponatremia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Metabolism and nutrition disorders - Oth",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Dyspnea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Respiratory, thoracic and mediastinal di",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Thromboembolic event",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 18,
"numEvents": 6,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 45,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
}
],
"frequencyThreshold": "0"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Progression Free Survival (MBC Cohort)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "18",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "OG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "22.4",
"comment": "NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.",
"groupId": "OG000",
"lowerLimit": "7.1",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "assessed up to 5 years",
"description": "Estimated using the product-limit method of Kaplan and Meier.\nFrom time of initial treatment until disease progression or death.\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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": "Months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "PFS was not performed on the LABC cohort (neoadjuvant patients).\nA more relevant analysis, Disease-free survival is present elsewhere in these results."
},
{
"type": "PRIMARY",
"title": "Five Year Disease-free Survival (LABC Cohort)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "29",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "OG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "96.3",
"groupId": "OG001",
"lowerLimit": "76.5",
"upperLimit": "99.5"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "assessed up to 5 years",
"description": "Estimated using the method of Kaplan-Meier.\nDisease-free survival is defined as the time from Initial treatment to recurrence of tumor or death",
"unitOfMeasure": "percentage of participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Analysis population included LABC participants who achieved pathologic response (pCR).\nMore appropriate PFS analysis for MBC cohort is presented elsewhere in these results."
},
{
"type": "SECONDARY",
"title": "Overall Response (MBC Cohort)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "18",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "OG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "13",
"groupId": "OG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "Up to 5 years",
"description": "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Overall response is not appropriate in the neoadjuvant or LABC cohort."
},
{
"type": "SECONDARY",
"title": "Five Year Overall Survival",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "18",
"groupId": "OG000"
},
{
"value": "45",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "OG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "54.5",
"groupId": "OG000",
"lowerLimit": "8.6",
"upperLimit": "86.1"
},
{
"value": "94.1",
"groupId": "OG001",
"lowerLimit": "77.6",
"upperLimit": "98.5"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "Assessed up to 5 years",
"description": "Estimated by the Kaplan-Meier method.\nFrom the initial date of treatment to date of death from any cause.",
"unitOfMeasure": "percentage of participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED"
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "FG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "18"
},
{
"groupId": "FG001",
"numSubjects": "45"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "18"
},
{
"groupId": "FG001",
"numSubjects": "45"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
}
]
}
]
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "18",
"groupId": "BG000"
},
{
"value": "45",
"groupId": "BG001"
},
{
"value": "63",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "BG001",
"title": "Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients",
"description": "<p>Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.</p><p>Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.</p><p>Nab-paclitaxel 100 mg/m2 IV weekly.</p><p>Treatment is scheduled to continue until:</p><p>A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors</p>"
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "49",
"groupId": "BG000",
"lowerLimit": "31",
"upperLimit": "65"
},
{
"value": "56",
"groupId": "BG001",
"lowerLimit": "31",
"upperLimit": "78"
},
{
"value": "54",
"groupId": "BG002",
"lowerLimit": "31",
"upperLimit": "78"
}
]
}
]
}
],
"paramType": "MEDIAN",
"unitOfMeasure": "years",
"dispersionType": "FULL_RANGE"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "18",
"groupId": "BG000"
},
{
"value": "45",
"groupId": "BG001"
},
{
"value": "63",
"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/Ethnicity, Customized",
"classes": [
{
"title": "African American",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Asian",
"categories": [
{
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "7",
"groupId": "BG001"
},
{
"value": "9",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Hispanic",
"categories": [
{
"measurements": [
{
"value": "10",
"groupId": "BG000"
},
{
"value": "19",
"groupId": "BG001"
},
{
"value": "29",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Non-Hispanic White",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "BG000"
},
{
"value": "17",
"groupId": "BG001"
},
{
"value": "22",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Unknown",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Region of Enrollment",
"classes": [
{
"title": "United States",
"categories": [
{
"measurements": [
{
"value": "18",
"groupId": "BG000"
},
{
"value": "45",
"groupId": "BG001"
},
{
"value": "63",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
}
]
}
}
},
{
"op": "add",
"path": "/documentSection",
"value": {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2017-07-27",
"size": 1340713,
"label": "Study Protocol and Statistical Analysis Plan",
"hasIcf": false,
"hasSap": true,
"filename": "Prot_SAP_000.pdf",
"typeAbbrev": "Prot_SAP",
"uploadDate": "2023-04-05T18:58",
"hasProtocol": true
}
]
}
}
}
]