{"description":"All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":49,"description":"Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.","id":"EG000","otherNumAffected":45,"otherNumAtRisk":49,"seriousNumAffected":11,"seriousNumAtRisk":49,"title":"Carfilzomib, Lenalidomide and Dexamethasone (KRd)"},{"deathsNumAffected":2,"deathsNumAtRisk":52,"description":"Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or intravenously on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.","id":"EG001","otherNumAffected":42,"otherNumAtRisk":52,"seriousNumAffected":20,"seriousNumAtRisk":52,"title":"Carfilzomib and Dexamethasone (Kd)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":49},{"groupId":"EG001","numAffected":19,"numAtRisk":52}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":52}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":49},{"groupId":"EG001","numAffected":12,"numAtRisk":52}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":52}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":49},{"groupId":"EG001","numAffected":12,"numAtRisk":52}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":52}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":49},{"groupId":"EG001","numAffected":9,"numAtRisk":52}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49},{"groupId":"EG001","numAffected":9,"numAtRisk":52}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":52}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":49},{"groupId":"EG001","numAffected":14,"numAtRisk":52}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":4,"numAtRisk":52}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":49},{"groupId":"EG001","numAffected":2,"numAtRisk":52}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":49},{"groupId":"EG001","numAffected":2,"numAtRisk":52}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":52}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":49},{"groupId":"EG001","numAffected":9,"numAtRisk":52}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49},{"groupId":"EG001","numAffected":2,"numAtRisk":52}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":52}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49},{"groupId":"EG001","numAffected":4,"numAtRisk":52}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49},{"groupId":"EG001","numAffected":5,"numAtRisk":52}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":5,"numAtRisk":52}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":49},{"groupId":"EG001","numAffected":6,"numAtRisk":52}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":52}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":49},{"groupId":"EG001","numAffected":22,"numAtRisk":52}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49},{"groupId":"EG001","numAffected":8,"numAtRisk":52}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":52}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":52}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":49},{"groupId":"EG001","numAffected":8,"numAtRisk":52}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Thrombotic microangiopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":52}],"term":"Acute cardiac event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":2,"numAtRisk":52}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Cardiotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":52}],"term":"Visual impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":52}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":52}],"term":"Neutropenic colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":52}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":52}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Amoebic dysentery"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":52}],"term":"COVID-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":52}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Pneumonia acinetobacter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Pneumonia viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":52}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":52}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":2,"numAtRisk":52}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Acute lung injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":52}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":52}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":52}],"term":"Pneumonitis"}],"timeFrame":"For all-cause mortality reporting, from enrollment until the end of trial or death date, whichever occurred earlier; median (min, max) time on trial was 8.7 (0.1, 37.2) months. For Adverse Event reporting, from the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months."}