{"analyses":[{"ciLowerLimit":"1.36","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.78","groupDescription":"Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0002","paramType":"Odds Ratio (OR)","paramValue":"1.95","statisticalComment":"Stratified by B2 microglobulin (\\<3.5 mg/L vs \\>=3.5 mg/L), number of prior lines of therapy (1 vs \\>=2), and immunomodulatory drug use at randomization","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"6.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"19.3","groupDescription":"Difference of Lenalidomide + Dexamethasone + Elotuzumab minus Lenalidomide + Dexamethasone computed using the method of DerSimonian and Laird (weighted average over the strata)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in ORR","paramValue":"12.7"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"73.6","upperLimit":"82.9","value":"78.5"},{"groupId":"OG001","lowerLimit":"60.1","upperLimit":"70.7","value":"65.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"321"},{"groupId":"OG001","value":"325"}],"units":"Participants"}],"description":"Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR \\[sCR\\], complete response \\[CR\\], very good partial response \\[VGPR\\], and partial response \\[PR\\]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (\\> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.","dispersionType":"95% Confidence Interval","groups":[{"description":"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug","id":"OG000","title":"Lenalidomide + Dexamethasone + Elotuzumab"},{"description":"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug","id":"OG001","title":"Lenalidomide + Dexamethasone"}],"paramType":"NUMBER","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization up to approximately 38 months","title":"Objective Response Rate (ORR)","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}