{"analyses":[{"ciLowerLimit":"0.338","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.921","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":"0.021","paramType":"Hazard Ratio (HR)","paramValue":"0.558","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":"42.1","upperLimit":"NA","value":"67.6"},{"groupId":"OG001","lowerLimit":"22.1","upperLimit":"51.6","value":"33.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"41"}],"units":"Participants"}],"description":"Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.","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\nDexamethasone 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\nDexamethasone 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 to study drug.","reportingStatus":"POSTED","timeFrame":"Up to data cut off of 03 August 2005; up to 24 months","title":"Kaplan-Meier Estimate of Duration of Response","type":"POST_HOC","unitOfMeasure":"weeks"}