{"analyses":[{"ciLowerLimit":"0.667","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.945","groupDescription":"The final analysis of OS was to be performed after 510 deaths occur. A total of 510 deaths would provide 85% power to detect, with a 1-sided significance level of 0.025, a hazard ratio of 0.765 corresponding to a 23.5% reduction in risk for death for CRd versus Rd (39.2 vs. 30.0 months, respectively).","groupIds":["OG000","OG001"],"nonInferiorityComment":"The stopping boundary for this analysis was 0.0231 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).","nonInferiorityType":"SUPERIORITY","pValue":"0.0045","paramType":"Hazard Ratio (HR)","paramValue":"0.794","statisticalComment":"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).","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"33.6","upperLimit":"44.4","value":"40.4"},{"groupId":"OG001","lowerLimit":"42.4","upperLimit":"52.8","value":"48.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"396"}],"units":"Participants"}],"description":"Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.","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 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.","title":"Overall Survival","type":"SECONDARY","unitOfMeasure":"months"}