{"eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":55,"description":"* Cycles 1-9\n\n  * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle\n  * Lenalidomide is administered orally on days 1-21 on a 28 days cycle\n  * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle\n* Cycle 10-24\n\n  * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle\n  * Lenalidomide is administered orally on days 1-21 on a 28 days cycle\n* Supportive measures consistent with optimal patient care may be given throughout the study\n\nIxazomib: Oral, proteasome inhibitor\n\nLenalidomide: Oral, immunomodulatory agent\n\nDexamethasone: Oral, steroid","id":"EG000","otherNumAffected":55,"otherNumAtRisk":55,"seriousNumAffected":15,"seriousNumAtRisk":55,"title":"Ixazomib"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 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(4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":55}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":55}],"term":"Blood bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":55}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":55}],"term":"Hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":55}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue 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(4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":55}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":55}],"term":"Bronchial infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":55}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":55}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":55}],"term":"Dry eye"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 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Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":55}],"term":"Lymphocyte count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55}],"term":"Atrial fibrillation"}],"timeFrame":"Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment."}