{"analyses":[{"ciLowerLimit":"0.48","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.67","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.57","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"886","upperLimit":"1129","value":"998.0"},{"groupId":"OG001","lowerLimit":"1543","upperLimit":"1853","value":"1703.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"297"},{"groupId":"OG001","value":"253"}],"units":"Participants"}],"description":"Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.","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 intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.","id":"OG001","title":"Fludarabine+Cyclophosphamide+Rituximab (FCR)"}],"paramType":"MEDIAN","populationDescription":"Participants from the Intent-to-treat population, that included all randomized participants, with PFS events.","reportingStatus":"POSTED","timeFrame":"Median observation time was approximately 66.4 months","title":"Final Analysis: Time to Progression-free Survival Event","type":"PRIMARY","unitOfMeasure":"Days"}