{"description":"All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).","eventGroups":[{"deathsNumAffected":7,"deathsNumAtRisk":10,"description":"Patients receive sunitinib 50 mg PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.","id":"EG000","otherNumAffected":6,"otherNumAtRisk":9,"seriousNumAffected":5,"seriousNumAtRisk":9,"title":"Treatment (Sunitinib)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Edema face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":9}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Localized edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Palmar-plantar erythrodysesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Skin ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Cheilitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Periodontal disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Rectal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":9}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Investigations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Paresthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Watering eyes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Eye disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Sore throat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Irregular menstruation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hot flashes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":9}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Thromboembolic event"}],"timeFrame":"Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration."}