{"analyses":[{"ciLowerLimit":"0.54","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.80","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.66","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"554","upperLimit":"797","value":"683.0"},{"groupId":"OG001","lowerLimit":"809","upperLimit":"1195","value":"969.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"217"},{"groupId":"OG001","value":"205"}],"units":"Participants"}],"description":"Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: 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 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":"Participants from the Intent-to-treat population, all randomized participants, who experienced a PFS event. Participants who did not have a PFS event at the time of the final analysis were censored at the date of the last contact.","reportingStatus":"POSTED","timeFrame":"Median observation time was approximately 5 years","title":"Final Analysis: Time to Progression-Free Survival Event","type":"PRIMARY","unitOfMeasure":"Days"}