{"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":1,"deathsNumAtRisk":7,"description":"Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12.\n\nParticipants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.","id":"EG000","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":3,"seriousNumAtRisk":6,"title":"Carfilzomib Plus Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Supraventricular extrasystoles"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Conjunctival haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Fractured coccyx"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Rib fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Scapula fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dizziness exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":6}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Emphysema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Sinus pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Large intestine perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hyperglycaemia"}],"timeFrame":"All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months)"}