{"analyses":[{"ciLowerLimit":"0.60","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.96","estimateComment":"The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the fludarabine+cyclophosphamide(FC) group.","groupDescription":"The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the fludarabine+cyclophosphamide+rituximab (FCR) group.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0218","paramType":"Hazard Ratio (HR)","paramValue":"0.76","statisticalComment":"non-stratified","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"556","upperLimit":"735","value":"660"},{"groupId":"OG001","lowerLimit":"670","upperLimit":"947","value":"813"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"276"},{"groupId":"OG001","value":"276"}],"units":"Participants"}],"description":"Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.","dispersionType":"95% Confidence Interval","groups":[{"description":"Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.","id":"OG000","title":"Fludarabine+Cyclophosphamide (FC)"},{"description":"Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.","id":"OG001","title":"Fludarabine+Cyclophosphamide+Rituximab (FCR)"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.","reportingStatus":"POSTED","timeFrame":"Mean observation time at time of analysis was approximately 26 months","title":"Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)","type":"PRIMARY","unitOfMeasure":"Days"}