{"analyses":[{"ciLowerLimit":"0.34","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.62","estimateComment":"Hazard ratio and its confidence interval (CI) were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.46","statisticalComment":"Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \\> 2 years), and disease histology (FL, MZL).","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA =Not enough events had occurred at the time of the data cut-off date","groupId":"OG000","lowerLimit":"22.9","upperLimit":"NA","value":"39.4"},{"groupId":"OG001","lowerLimit":"11.4","upperLimit":"16.7","value":"14.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"178"},{"groupId":"OG001","value":"180"}],"units":"Participants"}],"description":"Progression-free survival (PFS) was defined as the time from date of randomization into the study to the first observation of documented disease progression or death due to any cause, whichever occurred first. PFS was based on the data from the IRC review using the modified 2007 International Working Group Response Criteria (IWGRC) using FDA censoring rules.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received rituximab 375 mg/m\\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \\< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.","id":"OG000","title":"Rituximab + Lenalidomide (R^2)"},{"description":"Participants received rituximab 375 mg/m\\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.","id":"OG001","title":"Rituximab + Placebo"}],"paramType":"MEDIAN","populationDescription":"The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.","reportingStatus":"POSTED","timeFrame":"From randomization of study drug up to disease progression or death, which occurred first; up to the data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).","title":"Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC)","type":"PRIMARY","unitOfMeasure":"months"}