{"description":"Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":31,"description":"Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.","id":"EG000","otherNumAffected":31,"otherNumAtRisk":31,"seriousNumAffected":14,"seriousNumAtRisk":31,"title":"LBH589 + Bortezomib + Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":31}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and 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(21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":31}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":31}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":31}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Hypermagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Renal impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Coagulopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31}],"term":"Orthostatic hypotension"}],"timeFrame":"Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex)."}