{"analyses":[{"ciLowerLimit":"0.866","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.486","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":"0.359","pValueComment":"The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.","paramType":"Hazard Ratio (HR)","paramValue":"1.135","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.1","upperLimit":"16.1","value":"10.1"},{"groupId":"OG001","lowerLimit":"10.1","upperLimit":"24.1","value":"12.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"173"},{"groupId":"OG001","value":"172"}],"units":"Participants"}],"description":"The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status 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\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 includes all participants who were randomized to study drug; six ECOG scores were missing at the March 2008 cut-off.","reportingStatus":"POSTED","timeFrame":"Randomization to cut off date of 02 March 2008; up to 51 months","title":"Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)","type":"SECONDARY","unitOfMeasure":"weeks"}