{"description":"The safety population included all participants who received at least 1 dose of study treatment in Part 1 or Part 2. Participants were analyzed as per actual treatment received.","eventGroups":[{"description":"Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m\\^2) during cycle 1.","id":"EG000","otherNumAffected":21,"otherNumAtRisk":21,"seriousNumAffected":10,"seriousNumAtRisk":21,"title":"Part 1 - Bortezomib + Siltuximab"},{"description":"Bortezomib 1.3 mg/m\\^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.\n\nBortezomib 1.3 mg/m\\^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.","id":"EG001","otherNumAffected":135,"otherNumAtRisk":139,"seriousNumAffected":44,"seriousNumAtRisk":139,"title":"Part 2 - Bortezomib + Placebo"},{"description":"Bortezomib 1.3 mg/m\\^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m\\^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.\n\nDexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.","id":"EG002","otherNumAffected":140,"otherNumAtRisk":142,"seriousNumAffected":47,"seriousNumAtRisk":142,"title":"Part 2 - Bortezomib + Siltuximab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":21},{"groupId":"EG001","numAffected":46,"numAtRisk":139},{"groupId":"EG002","numAffected":45,"numAtRisk":142}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":21},{"groupId":"EG001","numAffected":16,"numAtRisk":139},{"groupId":"EG002","numAffected":38,"numAtRisk":142}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":21},{"groupId":"EG001","numAffected":5,"numAtRisk":139},{"groupId":"EG002","numAffected":13,"numAtRisk":142}],"term":"Lymphopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":21},{"groupId":"EG001","numAffected":53,"numAtRisk":139},{"groupId":"EG002","numAffected":86,"numAtRisk":142}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":21},{"groupId":"EG001","numAffected":65,"numAtRisk":139},{"groupId":"EG002","numAffected":83,"numAtRisk":142}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":6,"numAtRisk":139},{"groupId":"EG002","numAffected":6,"numAtRisk":142}],"term":"Vertigo"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":139},{"groupId":"EG002","numAffected":0,"numAtRisk":142}],"term":"Chalazion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":5,"numAtRisk":139},{"groupId":"EG002","numAffected":7,"numAtRisk":142}],"term":"Conjunctivitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":139},{"groupId":"EG002","numAffected":3,"numAtRisk":142}],"term":"Lacrimation Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":10,"numAtRisk":139},{"groupId":"EG002","numAffected":10,"numAtRisk":142}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":21},{"groupId":"EG001","numAffected":8,"numAtRisk":139},{"groupId":"EG002","numAffected":7,"numAtRisk":142}],"term":"Abdominal Pain Upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":139},{"groupId":"EG002","numAffected":3,"numAtRisk":142}],"term":"Aphthous Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":21},{"groupId":"EG001","numAffected":22,"numAtRisk":139},{"groupId":"EG002","numAffected":31,"numAtRisk":142}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":21},{"groupId":"EG001","numAffected":50,"numAtRisk":139},{"groupId":"EG002","numAffected":53,"numAtRisk":142}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":9,"numAtRisk":139},{"groupId":"EG002","numAffected":13,"numAtRisk":142}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":139},{"groupId":"EG002","numAffected":1,"numAtRisk":142}],"term":"Haemorrhoids"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":21},{"groupId":"EG001","numAffected":42,"numAtRisk":139},{"groupId":"EG002","numAffected":40,"numAtRisk":142}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":4,"numAtRisk":139},{"groupId":"EG002","numAffected":6,"numAtRisk":142}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":21},{"groupId":"EG001","numAffected":28,"numAtRisk":139},{"groupId":"EG002","numAffected":28,"numAtRisk":142}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":21},{"groupId":"EG001","numAffected":27,"numAtRisk":139},{"groupId":"EG002","numAffected":24,"numAtRisk":142}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":6,"numAtRisk":139},{"groupId":"EG002","numAffected":6,"numAtRisk":142}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":21},{"groupId":"EG001","numAffected":40,"numAtRisk":139},{"groupId":"EG002","numAffected":39,"numAtRisk":142}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":139},{"groupId":"EG002","numAffected":1,"numAtRisk":142}],"term":"Gait Disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":5,"numAtRisk":139},{"groupId":"EG002","numAffected":4,"numAtRisk":142}],"term":"Influenza Like Illness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":21},{"groupId":"EG001","numAffected":16,"numAtRisk":139},{"groupId":"EG002","numAffected":16,"numAtRisk":142}],"term":"Oedema Peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":27,"numAtRisk":139},{"groupId":"EG002","numAffected":8,"numAtRisk":142}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21},{"groupId":"EG001","numAffected":14,"numAtRisk":139},{"groupId":"EG002","numAffected":9,"numAtRisk":142}],"term":"Hepatic Function Abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":139},{"groupId":"EG002","numAffected":5,"numAtRisk":142}],"term":"Hyperbilirubinaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":11,"numAtRisk":139},{"groupId":"EG002","numAffected":14,"numAtRisk":142}],"term":"Bronchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":139},{"groupId":"EG002","numAffected":1,"numAtRisk":142}],"term":"Ear Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":2,"numAtRisk":139},{"groupId":"EG002","numAffected":4,"numAtRisk":142}],"term":"Herpes Simplex"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":13,"numAtRisk":139},{"groupId":"EG002","numAffected":4,"numAtRisk":142}],"term":"Herpes Zoster"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":2,"numAtRisk":139},{"groupId":"EG002","numAffected":6,"numAtRisk":142}],"term":"Hordeolum"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":13,"numAtRisk":139},{"groupId":"EG002","numAffected":15,"numAtRisk":142}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":4,"numAtRisk":139},{"groupId":"EG002","numAffected":7,"numAtRisk":142}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":11,"numAtRisk":139},{"groupId":"EG002","numAffected":14,"numAtRisk":142}],"term":"Respiratory Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21},{"groupId":"EG001","numAffected":7,"numAtRisk":139},{"groupId":"EG002","numAffected":5,"numAtRisk":142}],"term":"Rhinitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":21},{"groupId":"EG001","numAffected":12,"numAtRisk":139},{"groupId":"EG002","numAffected":14,"numAtRisk":142}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":7,"numAtRisk":139},{"groupId":"EG002","numAffected":12,"numAtRisk":142}],"term":"Urinary Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":21},{"groupId":"EG001","numAffected":20,"numAtRisk":139},{"groupId":"EG002","numAffected":20,"numAtRisk":142}],"term":"Weight Decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":3,"numAtRisk":139},{"groupId":"EG002","numAffected":5,"numAtRisk":142}],"term":"Weight Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":21},{"groupId":"EG001","numAffected":28,"numAtRisk":139},{"groupId":"EG002","numAffected":32,"numAtRisk":142}],"term":"Decreased Appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 16.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":21},{"groupId":"EG001","numAffected":2,"numAtRisk":139},{"groupId":"EG002","numAffected":6,"numAtRisk":142}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 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