{"description":"At each visit the investigator had to document any occurrence of adverse events (AEs) 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. In this study, only AEs in total duration of both Treatment Period I and II were planned to be collected on the study protocol and reported in this section. There were no plans to collect AEs for each Period.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)","id":"EG000","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":3,"seriousNumAtRisk":6,"title":"[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy"},{"deathsNumAffected":2,"deathsNumAtRisk":39,"description":"Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)","id":"EG001","otherNumAffected":31,"otherNumAtRisk":39,"seriousNumAffected":14,"seriousNumAtRisk":39,"title":"[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy"},{"deathsNumAffected":2,"deathsNumAtRisk":45,"description":"Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)","id":"EG002","otherNumAffected":37,"otherNumAtRisk":45,"seriousNumAffected":17,"seriousNumAtRisk":45,"title":"[Overall]; Combination Therapy + Ixazomib Therapy"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":4,"numAtRisk":45}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6},{"groupId":"EG001","numAffected":10,"numAtRisk":39},{"groupId":"EG002","numAffected":13,"numAtRisk":45}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":4,"numAtRisk":45}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":4,"numAtRisk":45}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":4,"numAtRisk":45}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":4,"numAtRisk":45}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":9,"numAtRisk":39},{"groupId":"EG002","numAffected":11,"numAtRisk":45}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":8,"numAtRisk":39},{"groupId":"EG002","numAffected":9,"numAtRisk":45}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":6,"numAtRisk":39},{"groupId":"EG002","numAffected":7,"numAtRisk":45}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":3,"numAtRisk":45}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":3,"numAtRisk":45}],"term":"Taste disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":6},{"groupId":"EG001","numAffected":3,"numAtRisk":39},{"groupId":"EG002","numAffected":7,"numAtRisk":45}],"term":"Rash"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Prinzmetal angina"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Duodenal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Bile duct stone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":5,"numAtRisk":39},{"groupId":"EG002","numAffected":5,"numAtRisk":45}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":2,"numAtRisk":45}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Tibia fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Tumour lysis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":2,"numAtRisk":39},{"groupId":"EG002","numAffected":2,"numAtRisk":45}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA/J version24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6},{"groupId":"EG001","numAffected":1,"numAtRisk":39},{"groupId":"EG002","numAffected":1,"numAtRisk":45}],"term":"Rash"}],"timeFrame":"Up to 39 months as a maximum"}