{"description":"At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded. The data reported are only serious and the other (not including serious) ADRs by events because only serious and the other ADRs were planned to be collected and assessed in this study. Seriousness of AEs by events was out of the scope for the data collection plan.","eventGroups":[{"deathsNumAffected":11,"deathsNumAtRisk":742,"description":"The usual adult dosage for oral administration was 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle was repeated for 6 cycles. The dose might be reduced appropriately according to the patient's condition. Participants received interventions as part of routine medical care.","id":"EG000","otherNumAffected":515,"otherNumAtRisk":742,"seriousNumAffected":193,"seriousNumAtRisk":742,"title":"Ixazomib 4 mg"}],"frequencyThreshold":"5.0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":313,"numAtRisk":742}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":742}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":178,"numAtRisk":742}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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infestations","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":742}],"term":"Bronchopulmonary aspergillosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":742}],"term":"Escherichia sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":742}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":742}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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v22.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":742}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":742}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":742}],"term":"Candida sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":742}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":742}],"term":"Enteritis 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v22.0","stats":[{"groupId":"EG000","numAffected":73,"numAtRisk":742}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":742}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":742}],"term":"Electrolyte imbalance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":742}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":742}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":742}],"term":"Tumour lysis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":742}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":742}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":742}],"term":"Altered state of 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v22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":742}],"term":"Taste disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":742}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":742}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":742}],"term":"Atrioventricular block complete"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":742}],"term":"Atrioventricular block second degree"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac 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