{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"title":"All SAEs Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]}],"title":"Grade 3-4 SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"AEs Leading to Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}]}],"title":"Grade 3-4 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Deaths"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Data cut-off February 2014.","groups":[{"description":"Elotuzumab was intravenously (IV) injected at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) AND 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).","id":"OG000","title":"Elotuzumab 10 mg/kg"},{"description":"Elotuzumab was intravenously (IV) injected at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) AND 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).","id":"OG001","title":"Elotuzumab 20 mg/kg"}],"paramType":"NUMBER","populationDescription":"All participants who received at least one dose of study medication were summarized (Treated Participants).","reportingStatus":"POSTED","timeFrame":"First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)","title":"Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Deaths","type":"PRIMARY","unitOfMeasure":"participants"}