{"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":37,"deathsNumAtRisk":54,"description":"Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.","id":"EG000","otherNumAffected":48,"otherNumAtRisk":52,"seriousNumAffected":22,"seriousNumAtRisk":52,"title":"Carfilzomib With Pomalidomide and Dexamethasone (KPd)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":52}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":52}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":52}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":52}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":52}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":52}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":52}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":52}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":52}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":52}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":52}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":52}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":52}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Pain in extremity"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Cardiac failure chronic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Left ventricular failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52}],"term":"COVID-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Cytomegalovirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Femoral neck fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Osteitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Renal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Respiratory tract infection"}],"timeFrame":"All-cause mortality: from enrollment until the end of study or death date, whichever occurs later; Median (min, max) time on study was 15.2 (0.0, 47.0) months. Adverse events: from the first dose of any study treatment until the end of study or 30 days after the last dose of any study treatment, whichever occurs earlier; Median (min, max) was 8.5 (1.0, 46.6) months"}