{"description":"All adverse events (AEs) which occurred after signed informed consent were documented in the source records and on the respective AE Case Report Form (CRF). Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Three doses of ipilimumab 3 mg/kg, were administered by intravenous infusion at 3 week intervals. A 6-week observation period followed the final dose.","id":"EG000","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Ipilimumab"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6}],"term":"Hyperbilirubinemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6}],"term":"Blood alkaline phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Alanine aminotransferase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Platelet count"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"White blood count"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Exfoliative rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dermatitis acneform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Blood creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Aspartate aminotransferase"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 7.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Vomiting"}],"timeFrame":"up to 13 weeks"}