{"description":"Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":6,"description":"Drug: Pomalidomide Cohort 1 = 2 mg/day, Days 1-28\n\nDrug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22","id":"EG000","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Phase I - Cohort 1 (Pomalidomide 2mg)"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Drug: Pomalidomide Cohort 2 = 3 mg/day, Days 1-28\n\nDrug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22","id":"EG001","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Phase I - Cohort 2 (Pomalidomide 3mg)"},{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Drug: Pomalidomide Cohort 3 = 4 mg/day, Days 1-28\n\nDrug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22","id":"EG002","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":3,"seriousNumAtRisk":6,"title":"Phase I - Cohort 3 (Pomalidomide 4mg)"},{"deathsNumAffected":1,"deathsNumAtRisk":12,"description":"Drug: Pomalidomide Maximum Tolerated Dose = 4 mg/day, Days 1-28\n\nDrug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22","id":"EG003","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":3,"seriousNumAtRisk":12,"title":"Phase II Expansion- Maximum Tolerated Dose"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":10,"numAtRisk":12,"numEvents":15}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":5}],"term":"weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":6,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":3}],"term":"visual blurring"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"urinary urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":6,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"urinary hesitancy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":12},{"groupId":"EG003","numAffected":5,"numAtRisk":12,"numEvents":6}],"term":"hyperuricemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":6},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":4}],"term":"upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"hypertriglyceridemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":5}],"term":"tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":9}],"term":"platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"sore throat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":5,"numAtRisk":12,"numEvents":7}],"term":"rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":3}],"term":"pruritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":3}],"term":"paresthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":5,"numAtRisk":12,"numEvents":6}],"term":"abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"pain-extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":6,"numAtRisk":6,"numEvents":9},{"groupId":"EG003","numAffected":9,"numAtRisk":12,"numEvents":16}],"term":"neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":4}],"term":"nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":3}],"term":"muscle disorder - cramping"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"mood alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":6,"numEvents":18},{"groupId":"EG003","numAffected":5,"numAtRisk":12,"numEvents":9}],"term":"lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"lightheadedness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"leukocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":5}],"term":"insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"infection - skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":9}],"term":"hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":4}],"term":"hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":6,"numEvents":7},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":3}],"term":"hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":6,"numAtRisk":6,"numEvents":12},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":4}],"term":"hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":4}],"term":"hoarseness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":8},{"groupId":"EG003","numAffected":8,"numAtRisk":12,"numEvents":10}],"term":"fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":7,"numAtRisk":12,"numEvents":9}],"term":"edema - limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":5,"numAtRisk":6,"numEvents":10},{"groupId":"EG003","numAffected":6,"numAtRisk":12,"numEvents":6}],"term":"dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":5,"numAtRisk":12,"numEvents":5}],"term":"dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":4}],"term":"dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":6,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":4}],"term":"diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":6,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":6,"numEvents":8},{"groupId":"EG003","numAffected":5,"numAtRisk":12,"numEvents":10}],"term":"creatinine elevated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":6}],"term":"cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":6,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":4}],"term":"constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":5}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":6,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":15},{"groupId":"EG003","numAffected":6,"numAtRisk":12,"numEvents":8}],"term":"anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":3}],"term":"anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":5}],"term":"alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"abdominal bloating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"hearing impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"hemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":6,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":4}],"term":"aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"myocardial infarction"}],"timeFrame":"6 years"}