{"analyses":[{"ciLowerLimit":"0.41","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.67","estimateComment":"Hazard Ratio of E-Ld to Ld. Stratified by stage of disease (International Staging System 1 - 2 vs 3)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.83"}],"classes":[{"categories":[{"measurements":[{"comment":"Median and upper limit were not estimable due to an insufficient number of participants with events.","groupId":"OG000","lowerLimit":"23.10","upperLimit":"NA","value":"NA"},{"comment":"Upper limit was not estimable due to an insufficient number of participants with events.","groupId":"OG001","lowerLimit":"16.66","upperLimit":"NA","value":"43.33"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"42"}],"units":"Participants"}],"description":"PFS is defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.","dispersionType":"95% Confidence Interval","groups":[{"description":"Lenalidomide\n\n25 mg taken orally once daily, Days 1 - 21 of each cycle\n\nDexamethasone\n\nAdministered on Days 1, 8, 15, and 22 of each cycle:\n\nOn weeks when elotuzumab is administered:\n\n* 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND\n* 8 mg IV (at least 45 minutes prior to elotuzumab administration)\n\nOn weeks when elotuzumab is NOT administered:\n\n\\- 40 mg taken orally\n\nElotuzumab (BMS-901608)\n\n* Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22\n* Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15\n* Cycle 19 and beyond: 20 mg/kg IV, Day 1","id":"OG000","title":"Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)"},{"description":"Lenalidomide\n\n25 mg taken orally once a day, Days 1 - 21 of each cycle\n\nDexamethasone\n\n40 mg taken orally, Days 1, 8, 15, and 22 of each cycle","id":"OG001","title":"Arm B: Lenalidomide + Dexamethasone"}],"paramType":"MEDIAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization to the date of first documented tumor progression or death due to any cause, up to approximately 72 months","title":"Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"Months"}