{"description":"All treated participants are included.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":9,"description":"Participants undergo ≤3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.3 mg/m\\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\\^2 IV on Days 1, 4, 8, and 11).","id":"EG000","otherNumAffected":9,"otherNumAtRisk":9,"seriousNumAffected":3,"seriousNumAtRisk":9,"title":"Vorinostat + Bortezomib"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9,"numEvents":8}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":9,"numEvents":98}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":9,"numEvents":32}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":9,"numEvents":99}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":9,"numEvents":189}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":9,"numEvents":16}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":9,"numEvents":44}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Gingival bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Gingivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":9,"numEvents":31}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":3}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":9,"numEvents":19}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":9,"numEvents":18}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9,"numEvents":9}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Drug-induced liver injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Enteritis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Hordeolum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":3}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":2}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9,"numEvents":8}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9,"numEvents":6}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2}],"term":"Blood albumin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":2}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":9}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2}],"term":"Blood phosphorus decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Blood potassium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9,"numEvents":4}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Electrocardiogram ST-T segment depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9,"numEvents":7}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":9,"numEvents":24}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":4}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":3}],"term":"Hypercreatininaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":20}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":2}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":2}],"term":"Hypermagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":9,"numEvents":24}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":5}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Tumour lysis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":2}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":3}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":5}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":2}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Haemorrhage subcutaneous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Onychoclasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":2}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":3}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Orthostatic hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Disseminated intravascular coagulation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9,"numEvents":2}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 13.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Decreased appetite"}],"timeFrame":"Up to 346 days (up to 30 days after the final dose of study treatment)"}