{"description":"Patients could remain on treatment after 6 months if they experienced a response to treatment.","eventGroups":[{"description":"Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.","id":"EG000","otherNumAffected":99,"otherNumAtRisk":102,"seriousNumAffected":23,"seriousNumAtRisk":102,"title":"Romidepsin"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":102}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":102}],"term":"Vomiting NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":102}],"term":"Diarrhoea NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":102}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":102}],"term":"Dry Mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":102}],"term":"Abdominal Pain NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":102}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":102}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":102}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":102}],"term":"Oedema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":102}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":102}],"term":"Rigors"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":102}],"term":"Skin Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":102}],"term":"Upper Respiratory Tract Infection NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":102}],"term":"Blood Magnesium Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":102}],"term":"Haemoglobin Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":102}],"term":"Weight Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":102}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":102}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":102}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":102}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":102}],"term":"Ageusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":102}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":102}],"term":"Anaemia NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":102}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":102}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":102}],"term":"Hypotension NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":102}],"term":"Neoplasm Progression NOS"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Anaemia NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":102}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Atrioventricular Block First Degree"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Atrioventricular Block Second Degree"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Cardiac Failure NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Cardiopulmonary Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Cardiac Tamponade"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Bradyarrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Supraventricular Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Ventricular Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Colonic Perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Rigors"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":102}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":102}],"term":"Disease Progression NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Pain Exacerbated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Oral Candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Oropharyngeal Candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Perineal Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":102}],"term":"Sepsis NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Skin Bacterial Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Staphylococcal Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Pharnygitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Tonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Electrocardiogram St Segment Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Troponin I Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Urine Output Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Hyperglycaemia NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Acidosis NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":102}],"term":"Neoplasm Progression NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":102}],"term":"Tumor Lysis Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Renal Failure Acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Laryngeal Stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Pleural Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Pulmonary Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Dermatitis Medicamentosa"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Haematoma NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":102}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":102}],"term":"Hypotension NOS"}],"timeFrame":"Treatment emergent events were collected from first dose to last visit which occurred approximately 1 month after the last dose. Patients were to be treated for 6 cycles (approximately 6 months) or until progression."}