{"description":"For Safety analyses all randomized participants who received at least 1 dose of study agents were analyzed. Data are presented for 117 participants in the treatment period (Part 1 and Part 2) and 21 participants who entered maintenance period (after achieving partial response or better in the Part 2 treatment period while receiving VPM+siltuximab)","eventGroups":[{"description":"Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.","id":"EG000","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":8,"seriousNumAtRisk":12,"title":"Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab"},{"description":"Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.","id":"EG001","otherNumAffected":51,"otherNumAtRisk":53,"seriousNumAffected":27,"seriousNumAtRisk":53,"title":"Part 2: VMP (Velcade+Melphalan+Prednisone)"},{"description":"Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.","id":"EG002","otherNumAffected":51,"otherNumAtRisk":52,"seriousNumAffected":30,"seriousNumAtRisk":52,"title":"Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab"},{"description":"Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks, during the maintenance period","id":"EG003","otherNumAffected":15,"otherNumAtRisk":21,"seriousNumAffected":1,"seriousNumAtRisk":21,"title":"Part 2, Maintenance Period: Siltuximab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 15.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":12},{"groupId":"EG001","numAffected":19,"numAtRisk":53},{"groupId":"EG002","numAffected":12,"numAtRisk":52},{"groupId":"EG003","numAffected":2,"numAtRisk":21}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and 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15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":53},{"groupId":"EG002","numAffected":1,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":21}],"term":"Leukocytoclastic Vasculitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":53},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":21}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":53},{"groupId":"EG002","numAffected":0,"numAtRisk":52},{"groupId":"EG003","numAffected":0,"numAtRisk":21}],"term":"Hypovolaemic Shock"}],"timeFrame":"Up to 30 days after the last dose of study medication"}