{"analyses":[{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.06","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0923","pValueComment":"Log Rank test was stratified by prior proteasome inhibitor use (Yes versus No), presence of at least 1 FcγRIIIa V allele (Yes versus No) and number of prior lines of therapy (1 versus 2 or 3) at randomization","paramType":"Hazard Ratio (HR)","paramValue":"0.72","statisticalComment":"Adjusted alpha level= 0.30","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.4","upperLimit":"12.2","value":"9.7"},{"groupId":"OG001","lowerLimit":"5.1","upperLimit":"10.2","value":"6.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"75"}],"units":"Participants"}],"description":"PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified International Myeloma Working Group (IMWG) criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase \\> 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.","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":"MEDIAN","populationDescription":"Intent to treat (ITT), all randomized participants were analyzed.","reportingStatus":"POSTED","timeFrame":"Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years","title":"Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants","type":"PRIMARY","unitOfMeasure":"Months"}