{"analyses":[{"ciLowerLimit":"-13.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"17.8","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Difference using Chan-Zhang method","paramValue":"2.3"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"53.2","upperLimit":"75.5","value":"64.9"},{"groupId":"OG001","lowerLimit":"50.7","upperLimit":"73.6","value":"62.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"75"}],"units":"Participants"}],"description":"ORR was calculated for participants with a best overall response (BOR) of partial response (PR) or better, including stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \\< 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level \\< 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \\< 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage.","dispersionType":"95% Confidence Interval","groups":[{"description":"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \\& 2: Days 1, 8 \\& 15; Cycles 3-8: Days 1 \\& 11; Cycle 9+: Days 1 \\& 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m\\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1\\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1\\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \\&11; Cycles 9+; Days 1 \\& 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1\\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \\&11; Cycles 9+; Days 1 \\& 15); Until criteria met for discontinuation","id":"OG000","title":"Elotuzumab + Bortezomib + Dexamethasone"},{"description":"Bortezomib: Solution; IV; 1.3 mg/m\\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug","id":"OG001","title":"Bortezomib + Dexamethasone"}],"paramType":"NUMBER","populationDescription":"All randomized participants were analyzed.","reportingStatus":"POSTED","timeFrame":"Randomization until 111 events, up to May 2014, approximately 2 years","title":"Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants","type":"SECONDARY","unitOfMeasure":"percentage of participants"}