{"description":"Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":4,"description":"Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.\n\n70 mg twice daily.\n\nDS-1594b: Given DS-1594b PO","id":"EG000","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":4,"seriousNumAtRisk":4,"title":"Phase I (DS-1594b) Cohort 1"},{"deathsNumAffected":3,"deathsNumAtRisk":4,"description":"Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.\n\n50 mg twice daily.\n\nDS-1594b: Given DS-1594b PO","id":"EG001","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":4,"seriousNumAtRisk":4,"title":"Phase I (DS-1594b) Cohort 2"},{"deathsNumAffected":2,"deathsNumAtRisk":5,"description":"Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.\n\n20 mg daily.\n\nDS-1594b: Given DS-1594b PO","id":"EG002","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":5,"seriousNumAtRisk":5,"title":"Phase I (DS-1594b) Cohort 3"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.\n\n50 mg daily.\n\nDS-1594b: Given DS-1594b PO","id":"EG003","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":3,"seriousNumAtRisk":3,"title":"Phase I (DS-1594b) Cohort 4"},{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.\n\n100 mg daily.\n\nDS-1594b: Given DS-1594b PO","id":"EG004","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":1,"seriousNumAtRisk":1,"title":"Phase I (DS-1594b) Cohort 5"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\n\nDS-1594b: Given DS-1594b PO","id":"EG005","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Phase 2 Cohort A and B (DS-1594b)"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\n\nDS-1594b: Given DS-1594b PO\n\nAzacitidine: Given IV or SC\n\nVenetoclax: Given PO","id":"EG006","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine)"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description.\n\nDS-1594b: Given DS-1594b PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IT\n\nDexamethasone: Given PO or IV\n\nFilgrastim: Given SC\n\nLeucovorin: Given IV or PO\n\nMesna: Given IV\n\nMethotrexate: Given IT\n\nPrednisone: Given PO\n\nRituximab: Given IV\n\nVincristine: Given IV","id":"EG007","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Phase 2 Cohort D (DS-1594b, Mini-HCVD)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":3,"numEvents":6},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Allergic rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":4,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":5,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":5},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"BUN increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Cardiac troponin I increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Cystitis noninfective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":6},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Disseminated intravascular coagulation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Electrocardiogram QT corrected interval prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Erythema multiforme"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Eye disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Fecal incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Fibrinogen decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hot flashes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypermagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":3,"numEvents":7},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hyperphosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypertriglyceridemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hyperuricemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":6},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":5},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":3,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":4},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Injury, poisoning and procedural complications - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"INR increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Investigations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Muscle cramp"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":4,"numEvents":8},{"groupId":"EG002","numAffected":5,"numAtRisk":5,"numEvents":12},{"groupId":"EG003","numAffected":3,"numAtRisk":3,"numEvents":8},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":8},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Palmar-plantar erythrodysesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Postnasal drip"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Reproductive system and breast disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Respiratory, thoracic and mediastinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Retinoic acid syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Rhinorrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Skin ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Thrush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Urine discoloration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Vitreous hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":3,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Weight loss"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Bacteremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Cardiac disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Cytomegalovirus infection reactivation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Eye disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Eye infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"General disorders and administration site conditions - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Infective myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Joint infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Middle ear inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Nervous system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Retinoic acid syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Retroperitoneal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Tumor lysis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Wound infection"}],"timeFrame":"Up to the date of failure or death from any cause, approximately 3 years 7 months."}