{"description":"Ixazomib Safety Population included all participants who received at least 1 dose of ixazomib. Placebo Safety Population included all participants who received at least 1 dose of placebo. Adverse events are presented per treatment received during the course of the study.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":35,"description":"Participants received ixazomib 3 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 1 through 4, during which if the participants tolerated the initial dose, the dose was escalated to ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 5 through 26, or until documented progressive disease (PD) or intolerable toxicity, whichever occurred first (cycle length=28 days).","id":"EG000","otherNumAffected":33,"otherNumAtRisk":35,"seriousNumAffected":11,"seriousNumAtRisk":35,"title":"Ixazomib"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Participants received ixazomib placebo-matching capsules, orally, once on Days 1, 8, and 15 of each cycle until Protocol Amendment 08 was implemented (cycle length=28 days).","id":"EG001","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"title":"Placebo"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":35},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"Breath odour"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":35},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":35},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"Tongue ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Hepatic steatosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":35},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":35},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Hypercholesterolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Hypertriglyceridaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue 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osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":35},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"Cerebrovascular insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system 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complications","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Post procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Periarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue 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