{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":9,"description":"Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.\n\nLenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.\n\nElotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.\n\nLenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.\n\nDexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.\n\nDuring the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.","id":"EG000","otherNumAffected":2,"otherNumAtRisk":9,"seriousNumAffected":3,"seriousNumAtRisk":9,"title":"A: Elotuzumab + Lenalidomide at 25 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":9,"description":"Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.\n\nLenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.\n\nElotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.\n\nLenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.\n\nDexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.\n\nDuring the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.","id":"EG001","otherNumAffected":1,"otherNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"title":"B: Elotuzumab + Lenalidomide at 10 mg"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE Version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE Version 5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE Version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0}],"term":"Syncope"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE Version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE Version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0}],"term":"Lung Infection - Probable Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0}],"term":"Lung Infection"}],"timeFrame":"Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months."}