{"analyses":[{"ciPctValue":"95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0002","statisticalComment":"non-stratified","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"545","upperLimit":"731","value":"586"},{"groupId":"OG001","lowerLimit":"756","upperLimit":"1187","value":"874"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"276"},{"groupId":"OG001","value":"276"}],"units":"Participants"}],"description":"Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS 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":"Event-free Survival (EFS)","type":"SECONDARY","unitOfMeasure":"Days"}