{"description":"NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.","eventGroups":[{"deathsNumAffected":9,"deathsNumAtRisk":131,"description":"Participants received romidepsin 14 mg/m\\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.","id":"EG000","otherNumAffected":124,"otherNumAtRisk":131,"seriousNumAffected":62,"seriousNumAtRisk":131,"title":"Romidepsin"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":131}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":131}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":131}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":131}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":131}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":131}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":131}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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17.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":131}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":131}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":131}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":131}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 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17.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":131}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":131}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":131}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":131}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":131}],"term":"Anaemia haemolytic 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17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":131}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Cardiogenic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Subendocardial ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Angle closure glaucoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Intussusception"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Lower gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":131}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Nephrolithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Pelvi-ureteric obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":131}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":131}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":131}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":131}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":131}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":131}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":131}],"term":"Thrombosis"}],"timeFrame":"Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days."}