{"description":"All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety population defined as participants who had received at least 1 administration of any study treatment (partial or complete) and were analyzed according to treatment actually received.","eventGroups":[{"deathsNumAffected":217,"deathsNumAtRisk":356,"description":"Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m\\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \\[IMWG\\] criteria). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab.","id":"EG000","otherNumAffected":331,"otherNumAtRisk":354,"seriousNumAffected":117,"seriousNumAtRisk":354,"title":"Velcade, Melphalan and Prednisone (VMP)"},{"deathsNumAffected":172,"deathsNumAtRisk":350,"description":"Participants received Velcade 1.3 mg/m\\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).","id":"EG001","otherNumAffected":329,"otherNumAtRisk":346,"seriousNumAffected":186,"seriousNumAtRisk":346,"title":"Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V23.0","stats":[{"groupId":"EG000","numAffected":129,"numAtRisk":354},{"groupId":"EG001","numAffected":110,"numAtRisk":346}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V23.0","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":354},{"groupId":"EG001","numAffected":47,"numAtRisk":346}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V23.0","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":354},{"groupId":"EG001","numAffected":39,"numAtRisk":346}],"term":"Lymphopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V23.0","stats":[{"groupId":"EG000","numAffected":186,"numAtRisk":354},{"groupId":"EG001","numAffected":174,"numAtRisk":346}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA V23.0","stats":[{"groupId":"EG000","numAffected":189,"numAtRisk":354},{"groupId":"EG001","numAffected":172,"numAtRisk":346}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA V23.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":354},{"groupId":"EG001","numAffected":20,"numAtRisk":346}],"term":"Atrial Fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V23.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":354},{"groupId":"EG001","numAffected":26,"numAtRisk":346}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA V23.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":354},{"groupId":"EG001","numAffected":21,"numAtRisk":346}],"term":"Abdominal Pain 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