{"analyses":[{"ciLowerLimit":"0.498","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.070","estimateComment":"Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dexamethasone:Placebo/Dexamethasone)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.105","paramType":"Hazard Ratio (HR)","paramValue":"0.730","statisticalComment":"The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA: Data not considered materialized or estimable at this time point","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"NA: Data not considered materialized or estimable at this time point","groupId":"OG001","lowerLimit":"71.6","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"175"}],"units":"Participants"}],"description":"OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.\n\nPulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.","id":"OG000","title":"Lenalidomide Plus Dexamethasone"},{"description":"Placebo PO daily on Days 1 to 28 of each 28 day cycle.\n\nPulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.","id":"OG001","title":"Placebo Plus Dexamethasone"}],"paramType":"MEDIAN","populationDescription":"Intent to Treat population includes all participants who were randomized.","reportingStatus":"POSTED","timeFrame":"Randomization to data cut off of 03 August 2005; up to 24 months","title":"Kaplan-Meier Estimate of Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"weeks"}