{"eventGroups":[{"description":"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.\n\nPatients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.","id":"EG000","otherNumAffected":32,"otherNumAtRisk":32,"seriousNumAffected":14,"seriousNumAtRisk":32,"title":"Romidepsin + Bortezomib"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":32}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":32}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":32}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Aphthous stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":32}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":32}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":32}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":32}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":32}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Infusion site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":32}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":32}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":32}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Rash macular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Pneumonia primary atypical"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Pneumonia staphylococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Subdural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Electrocardiogram T wave inversion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Electrocardiogram QT prolongation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (10.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32}],"term":"Venous thrombosis"}],"timeFrame":"up to 9 months"}