{"analyses":[{"ciLowerLimit":"0.570","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.834","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"< 0.0001","pValueComment":"Analysis was stratified by β2 microglobulin levels (\\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes)","paramType":"Hazard Ratio (HR)","paramValue":"0.690","statisticalComment":"The stopping boundary for this analysis was 0.0127 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.0","upperLimit":"20.6","value":"17.6"},{"groupId":"OG001","lowerLimit":"23.3","upperLimit":"30.5","value":"26.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"396"}],"units":"Participants"}],"description":"Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.","id":"OG000","title":"Lenalidomide and Dexamethasone (Rd)"},{"description":"Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.","id":"OG001","title":"Carfilzomib, Lenalidomide, and Dexamethasone (CRd)"}],"paramType":"MEDIAN","populationDescription":"ITT analysis set comprised of all randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.","title":"Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}