{"analyses":[{"ciLowerLimit":"0.398","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.964","estimateComment":"Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.032","paramType":"Hazard Ratio (HR)","paramValue":"0.619","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":[{"groupId":"OG000","lowerLimit":"42.1","upperLimit":"105.6","value":"68.1"},{"groupId":"OG001","lowerLimit":"22.1","upperLimit":"51.6","value":"33.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"105"},{"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. Pulse dexamethasone 40 mg 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 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.\n\nAfter the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.","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 Mar 2008; up to 51 months","title":"Kaplan-Meier Estimate of Duration of Response (Cut-off at a Later Date of 03 March 2008)","type":"POST_HOC","unitOfMeasure":"weeks"}