{"analyses":[{"ciLowerLimit":"0.54","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.79","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.65","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"548","upperLimit":"747","value":"630.0"},{"groupId":"OG001","lowerLimit":"777","upperLimit":"1187","value":"932.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"218"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"description":"Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause.","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 had an EFS event. Participants who did not have an ESF 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 Event-Free Survival Event","type":"SECONDARY","unitOfMeasure":"Days"}