{"description":"At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.","eventGroups":[{"deathsNumAffected":24,"deathsNumAtRisk":295,"description":"Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. 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v24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":295}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Colitis ischaemic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Crohn's disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Gastric ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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v24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":295}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Cardiac death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"The reasons of events are not determined because assessment findings were insufficient to specify the reason.","organSystem":"General disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Cholecystitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":295}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":295}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":295}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":295}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":295}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":295}],"term":"Pneumonia influenzal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":295}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Bronchitis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Bronchopulmonary aspergillosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Cytomegalovirus enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Enteritis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Enterocolitis bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Periodontitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Pneumocystis jirovecii pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Pneumonia cryptococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Pneumonia pneumococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Pulmonary 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and procedural complications","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Subdural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Bone contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Heat illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Radiation oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":295}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":295}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":295}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":295}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Tumour lysis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Intervertebral disc protrusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":295}],"term":"Plasma cell myeloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Breast cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Cerebellar haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Loss of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":295}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":295}],"term":"Renal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Nephropathy toxic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Urinary tract obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":295}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":295}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Pulmonary amyloidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":295}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Erythema multiforme"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Toxic skin eruption"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Aortic aneurysm rupture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA/J v24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":295}],"term":"Shock"}],"timeFrame":"Up to 36 months as a maximum"}