{"analyses":[{"ciLowerLimit":"0.240","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.438","estimateComment":"Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dex:Placebo/Dexamethasone)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","paramType":"Hazard Ratio (HR)","paramValue":"0.324","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":"Unable to provide as data not yet estimable","groupId":"OG000","lowerLimit":"40.9","upperLimit":"NA","value":"52.1"},{"groupId":"OG001","lowerLimit":"16.6","upperLimit":"20.7","value":"20.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"175"}],"units":"Participants"}],"description":"Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.","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 included all participants who were randomized.","reportingStatus":"POSTED","timeFrame":"From randomization up to cut-off date of 03 August 2005; up to 24 months","title":"Kaplan-Meier Estimate of Time to Tumor Progression (TTP)","type":"PRIMARY","unitOfMeasure":"weeks"}