{"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":3,"deathsNumAtRisk":36,"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \\[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\\] and cyclophosphamide (CYC) 300 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.","id":"EG000","otherNumAffected":34,"otherNumAtRisk":36,"seriousNumAffected":17,"seriousNumAtRisk":36,"title":"Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)"},{"deathsNumAffected":2,"deathsNumAtRisk":34,"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \\[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\\] and cyclophosphamide (CYC) 400 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.","id":"EG001","otherNumAffected":34,"otherNumAtRisk":34,"seriousNumAffected":20,"seriousNumAtRisk":34,"title":"Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)"},{"deathsNumAffected":5,"deathsNumAtRisk":78,"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.","id":"EG002","otherNumAffected":69,"otherNumAtRisk":78,"seriousNumAffected":30,"seriousNumAtRisk":78,"title":"Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":34},{"groupId":"EG002","numAffected":21,"numAtRisk":78}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":36},{"groupId":"EG001","numAffected":4,"numAtRisk":34},{"groupId":"EG002","numAffected":12,"numAtRisk":78}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":36},{"groupId":"EG001","numAffected":4,"numAtRisk":34},{"groupId":"EG002","numAffected":6,"numAtRisk":78}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":4,"numAtRisk":34},{"groupId":"EG002","numAffected":8,"numAtRisk":78}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":34},{"groupId":"EG002","numAffected":5,"numAtRisk":78}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":6,"numAtRisk":78}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":5,"numAtRisk":78}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":34},{"groupId":"EG002","numAffected":3,"numAtRisk":78}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":5,"numAtRisk":78}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":3,"numAtRisk":78}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":4,"numAtRisk":78}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":3,"numAtRisk":78}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Viral upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":36},{"groupId":"EG001","numAffected":9,"numAtRisk":34},{"groupId":"EG002","numAffected":26,"numAtRisk":78}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":36},{"groupId":"EG001","numAffected":10,"numAtRisk":34},{"groupId":"EG002","numAffected":19,"numAtRisk":78}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":36},{"groupId":"EG001","numAffected":9,"numAtRisk":34},{"groupId":"EG002","numAffected":9,"numAtRisk":78}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":36},{"groupId":"EG001","numAffected":7,"numAtRisk":34},{"groupId":"EG002","numAffected":8,"numAtRisk":78}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":34},{"groupId":"EG002","numAffected":6,"numAtRisk":78}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":4,"numAtRisk":78}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":4,"numAtRisk":78}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":36},{"groupId":"EG001","numAffected":11,"numAtRisk":34},{"groupId":"EG002","numAffected":19,"numAtRisk":78}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":36},{"groupId":"EG001","numAffected":16,"numAtRisk":34},{"groupId":"EG002","numAffected":15,"numAtRisk":78}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36},{"groupId":"EG001","numAffected":4,"numAtRisk":34},{"groupId":"EG002","numAffected":18,"numAtRisk":78}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":4,"numAtRisk":78}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":4,"numAtRisk":78}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Iron deficiency anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":36},{"groupId":"EG001","numAffected":7,"numAtRisk":34},{"groupId":"EG002","numAffected":15,"numAtRisk":78}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":36},{"groupId":"EG001","numAffected":9,"numAtRisk":34},{"groupId":"EG002","numAffected":5,"numAtRisk":78}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36},{"groupId":"EG001","numAffected":6,"numAtRisk":34},{"groupId":"EG002","numAffected":4,"numAtRisk":78}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":4,"numAtRisk":78}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":4,"numAtRisk":78}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":36},{"groupId":"EG001","numAffected":10,"numAtRisk":34},{"groupId":"EG002","numAffected":10,"numAtRisk":78}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":7,"numAtRisk":78}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":34},{"groupId":"EG002","numAffected":5,"numAtRisk":78}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":34},{"groupId":"EG002","numAffected":3,"numAtRisk":78}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":3,"numAtRisk":78}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36},{"groupId":"EG001","numAffected":6,"numAtRisk":34},{"groupId":"EG002","numAffected":6,"numAtRisk":78}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":5,"numAtRisk":34},{"groupId":"EG002","numAffected":7,"numAtRisk":78}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":36},{"groupId":"EG001","numAffected":4,"numAtRisk":34},{"groupId":"EG002","numAffected":2,"numAtRisk":78}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":6,"numAtRisk":78}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":4,"numAtRisk":78}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":4,"numAtRisk":78}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":3,"numAtRisk":78}],"term":"Rash erythematous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":3,"numAtRisk":78}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":3,"numAtRisk":78}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":3,"numAtRisk":78}],"term":"Rash macular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Erythema multiforme"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Rash pruritic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":4,"numAtRisk":34},{"groupId":"EG002","numAffected":7,"numAtRisk":78}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":6,"numAtRisk":78}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":4,"numAtRisk":34},{"groupId":"EG002","numAffected":2,"numAtRisk":78}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":34},{"groupId":"EG002","numAffected":3,"numAtRisk":78}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":4,"numAtRisk":78}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":34},{"groupId":"EG002","numAffected":10,"numAtRisk":78}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":7,"numAtRisk":34},{"groupId":"EG002","numAffected":2,"numAtRisk":78}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":2,"numAtRisk":78}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":5,"numAtRisk":78}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Glaucoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":2,"numAtRisk":78}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":34},{"groupId":"EG002","numAffected":3,"numAtRisk":78}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":3,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Atrial fibrillation"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One treatment-emergent death occurred during treatment with Ixazomib 4.0 mg + CYC 400 mg/m\\^2 + DEX 40 mg (NDMM) and is not related.","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":3,"numAtRisk":78}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":2,"numAtRisk":78}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":2,"numAtRisk":78}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Localised infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Pseudomembranous colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Escherichia sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Pneumocystis jirovecii pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One treatment-emergent death occurred during treatment with Ixazomib 4.0 mg + CYC 300 mg/m\\^2 + DEX 40 mg (RRMM) and is related.","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Pseudomonal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Pneumonia respiratory syncytial viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":2,"numAtRisk":78}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Melaena"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One treatment-emergent death occurred during treatment with Ixazomib 4.0 mg + CYC 300 mg/m\\^2 + DEX 40 mg (NDMM) and is not related.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Rectal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Acute coronary syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One treatment-emergent (TE) death occurred during treatment with Ixazomib 4.0 mg + CYC 300 mg/m\\^2 + DEX 40 mg (RRMM) and is not related.","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":2,"numAtRisk":78}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":2,"numAtRisk":78}],"term":"Plasma cell myeloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Bladder cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Benign bone neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Rectal adenocarcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Gastric cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Myelodysplastic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Brain neoplasm benign"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Oesophageal carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"1 TE death occurred during treatment with Ixazomib 4.0 mg + CYC 300 mg/m\\^2 + DEX 40 mg (NDMM), 1 with Ixazomib 4.0 mg + CYC 400 mg/m\\^2 + DEX 40 mg (NDMM) and 1 with Ixazomib 4.0 mg + CYC 300 mg/m\\^2 + DEX 40 mg (RRMM) and all 3 are not related.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":2,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One treatment-emergent death occurred during treatment with Ixazomib 4.0 mg + CYC 300 mg/m\\^2 + DEX 40 mg (NDMM) and is not related.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":2,"numAtRisk":78}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One treatment-emergent death occurred during treatment with Ixazomib 4.0 mg + CYC 300 mg/m\\^2 + DEX 40 mg (RRMM) and is related.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One treatment-emergent death occurred during treatment with Ixazomib 4.0 mg + CYC 300 mg/m\\^2 + DEX 40 mg (RRMM) and is not related.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Carpal tunnel syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Osteolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Tendon rupture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":2,"numAtRisk":78}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Pemphigus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Rash macular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Light chain analysis increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":0,"numAtRisk":34},{"groupId":"EG002","numAffected":1,"numAtRisk":78}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":36},{"groupId":"EG001","numAffected":1,"numAtRisk":34},{"groupId":"EG002","numAffected":0,"numAtRisk":78}],"term":"Bone marrow failure"}],"timeFrame":"First dose of study drug through 30 days after last dose of drug (Up to 45 months)"}