{"description":"All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.","eventGroups":[{"deathsNumAffected":91,"deathsNumAtRisk":126,"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23.\n\nParticipants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.","id":"EG000","otherNumAffected":123,"otherNumAtRisk":123,"seriousNumAffected":68,"seriousNumAtRisk":123,"title":"Carfilzomib With Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":123}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":123}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":123}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":123}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":123}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":123}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":123}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":123}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":123}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":123}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":123}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":123}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":123}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":123}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":123}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":123}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":123}],"term":"Bilirubin conjugated increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":123}],"term":"Blood albumin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":123}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":123}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":123}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":123}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":123}],"term":"Blood phosphorus increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":123}],"term":"Blood potassium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":123}],"term":"Blood pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":123}],"term":"Blood urea increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":123}],"term":"Blood uric acid increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":123}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":123}],"term":"Lymphocyte percentage decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":123}],"term":"Mean cell volume increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":123}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":123}],"term":"Neutrophil count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":123}],"term":"Neutrophil percentage increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":123}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":123}],"term":"Prealbumin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":123}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":123}],"term":"White blood cell count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":123}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":123}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":123}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":123}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":123}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":123}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":123}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":123}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":123}],"term":"Hypoproteinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":123}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":123}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":123}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":123}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":123}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":123}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":123}],"term":"Hypoglycaemia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123}],"term":"Cardiac amyloidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Cardiac failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":123}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Infusion site extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":123}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Bronchiolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Escherichia sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123}],"term":"Localised infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Periodontitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":123}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":123}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":123}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":123}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":123}],"term":"Plasma cell myeloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Myelopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":123}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Obstructive airways disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Organising pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Lipoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Cerebral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":123}],"term":"Nerve compression"}],"timeFrame":"All-cause mortality is reported from the date enrolled until the end of study, median (minimum, maximum) time on study was 14.32 (0.066, 47.28) months. Adverse events are reported from the first dose of any study treatment up to 30 days after the end of study treatment, or initiation of new antimyeloma therapy, whichever occurred first; median (minimum, maximum) duration of treatment was 20.3 (0.3, 203) weeks."}