{"description":"Per protocol, all grades of peripheral neuropathy and skeletal events, Grade 3/4 AEs, and all SAEs were recorded. There may be grade 1 or 2 events that were not required to be collected.","eventGroups":[{"description":"Participants received bortezomib (Velcade) 1.3 mg/m\\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).","id":"EG000","otherNumAffected":57,"otherNumAtRisk":165,"seriousNumAffected":88,"seriousNumAtRisk":165,"title":"Bortezomib and Dexamethasone"},{"description":"Participants received bortezomib 1.3 mg/m\\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).","id":"EG001","otherNumAffected":68,"otherNumAtRisk":158,"seriousNumAffected":92,"seriousNumAtRisk":158,"title":"Bortezomib, Thalidomide, and Dexamethasone"},{"description":"Participants received bortezomib 1.3 mg/m\\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).","id":"EG002","otherNumAffected":68,"otherNumAtRisk":163,"seriousNumAffected":83,"seriousNumAtRisk":163,"title":"Bortezomib, Melphalan and Prednisone"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":165},{"groupId":"EG001","numAffected":2,"numAtRisk":158},{"groupId":"EG002","numAffected":6,"numAtRisk":163}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":7,"numAtRisk":163}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":165},{"groupId":"EG001","numAffected":3,"numAtRisk":158},{"groupId":"EG002","numAffected":3,"numAtRisk":163}],"term":"Blood sodium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":165},{"groupId":"EG001","numAffected":3,"numAtRisk":158},{"groupId":"EG002","numAffected":3,"numAtRisk":163}],"term":"Blood uric acid increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":6,"numAtRisk":163}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":3,"numAtRisk":163}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":1,"numAtRisk":163}],"term":"Blood urea increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":1,"numAtRisk":163}],"term":"Protein total increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":3,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":1,"numAtRisk":163}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":165},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":1,"numAtRisk":163}],"term":"Troponin T increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Blood calcium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":1,"numAtRisk":163}],"term":"Blood chloride decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":1,"numAtRisk":163}],"term":"Blood creatinine decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":165},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Blood immunoglobulin G increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Blood phosphorus decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Blood potassium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Breath sounds abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":165},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Carbon monoxide diffusing capacity 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decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":165},{"groupId":"EG001","numAffected":4,"numAtRisk":158},{"groupId":"EG002","numAffected":2,"numAtRisk":163}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":165},{"groupId":"EG001","numAffected":2,"numAtRisk":158},{"groupId":"EG002","numAffected":1,"numAtRisk":163}],"term":"Post herpetic neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":165},{"groupId":"EG001","numAffected":2,"numAtRisk":158},{"groupId":"EG002","numAffected":1,"numAtRisk":163}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":165},{"groupId":"EG001","numAffected":2,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Balance disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":165},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":3,"numAtRisk":163}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":1,"numAtRisk":163}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":2,"numAtRisk":163}],"term":"Peripheral sensorimotor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":165},{"groupId":"EG001","numAffected":2,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":165},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":1,"numAtRisk":163}],"term":"Ageusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":2,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Cranial nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":2,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":1,"numAtRisk":163}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Hypogeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Polyneuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":165},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":163}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (15.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":165},{"groupId":"EG001","numAffected":5,"numAtRisk":158},{"groupId":"EG002","numAffected":3,"numAtRisk":163}],"term":"Rash pruritic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 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