{"analyses":[{"ciLowerLimit":"0.26","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.53","groupIds":["OG000","OG001"],"nonInferiorityComment":"This study was designed to have 80% power, with the use of the log-rank test at a one-sided significance level of 0.05, to detect a hazard ratio of 1.4, assuming proportional hazards and an exponential time to event distribution. Under the assumed framework, 309 events were expected. The expected drop out rate before randomization was 15%.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","pValue":"<0.001","pValueComment":"Participants were randomized with the use of a permuted-block design stratified by beta 2 microglobulin, prior use of thalidomide and prior use of lenalidomide. TTP was monitored with the use of a group sequential design for superiority and futility.","paramType":"Hazard Ratio (HR)","paramValue":"0.36","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment","groupId":"OG000","lowerLimit":"36","upperLimit":"NA","value":"39"},{"groupId":"OG001","lowerLimit":"18","upperLimit":"28","value":"21"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"229"}],"units":"Participants"}],"description":"Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.\n\nProgression was defined per the International Myeloma Working Group definition as one more of the following:\n\n* 25% increase in serum M-component (absolute increase \\>= 0.5g/dl)\n* 25% increase in urine M-component (absolute increase \\>= 200mg/24hour\n* 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \\>= 10mg/dl)\n* 25 % increase in bone marrow plasma cell percentage (absolute increase of \\>=10%)\n* Definite development of new bone lesion or soft tissue plasmacytomas\n* Development of hypercalcemia","dispersionType":"95% Confidence Interval","groups":[{"description":"Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.","id":"OG000","title":"Lenalidomide Maintenance"},{"description":"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.\n\n(closed as of 12/17/09)","id":"OG001","title":"Placebo Maintenance"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"Duration of study (up to 10years)","title":"Time to Progression","type":"PRIMARY","unitOfMeasure":"months"}