{"description":"All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the \"Other Adverse Events\" section include all TEAEs (non-serious AEs and serious AEs).","eventGroups":[{"deathsNumAffected":180,"deathsNumAtRisk":246,"description":"Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.\n\nMelflufen: Intravenous infusion\n\nDexamethasone: Oral tablets","id":"EG000","otherNumAffected":227,"otherNumAtRisk":228,"seriousNumAffected":99,"seriousNumAtRisk":228,"title":"Arm A: Melflufen+Dexamethasone"},{"deathsNumAffected":169,"deathsNumAtRisk":249,"description":"Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.\n\nPomalidomide: Oral capsules\n\nDexamethasone: Oral tablets","id":"EG001","otherNumAffected":243,"otherNumAtRisk":246,"seriousNumAffected":124,"seriousNumAtRisk":246,"title":"Arm B: Pomalidomide+Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":137,"numAtRisk":228,"numEvents":795},{"groupId":"EG001","numAffected":115,"numAtRisk":246,"numEvents":421}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":154,"numAtRisk":228,"numEvents":487},{"groupId":"EG001","numAffected":97,"numAtRisk":246,"numEvents":238}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":161,"numAtRisk":228,"numEvents":918},{"groupId":"EG001","numAffected":50,"numAtRisk":246,"numEvents":149}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":228,"numEvents":89},{"groupId":"EG001","numAffected":11,"numAtRisk":246,"numEvents":18}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":228,"numEvents":33},{"groupId":"EG001","numAffected":27,"numAtRisk":246,"numEvents":43}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":228,"numEvents":16},{"groupId":"EG001","numAffected":29,"numAtRisk":246,"numEvents":42}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":228,"numEvents":26},{"groupId":"EG001","numAffected":36,"numAtRisk":246,"numEvents":47}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":228,"numEvents":17},{"groupId":"EG001","numAffected":16,"numAtRisk":246,"numEvents":24}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":228,"numEvents":12},{"groupId":"EG001","numAffected":20,"numAtRisk":246,"numEvents":24}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":228,"numEvents":15},{"groupId":"EG001","numAffected":14,"numAtRisk":246,"numEvents":16}],"term":"COVID-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 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study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months."}