{"analyses":[{"ciPctValue":"95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.8842","statisticalComment":"non-stratified","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit could not be estimated due to too low number of events at time of analysis.","groupId":"OG000","lowerLimit":"791","upperLimit":"NA","value":"1285"},{"comment":"The upper limit could not be estimated due to too low number of events at time of analysis.","groupId":"OG001","lowerLimit":"938","upperLimit":"NA","value":"1204"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"67"}],"units":"Participants"}],"description":"Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) 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 for patients with a Best Overall Response of Complete Response.","reportingStatus":"POSTED","timeFrame":"Mean observation time at time of analysis was approximately 26 months","title":"Disease-free Survival (DFS)","type":"SECONDARY","unitOfMeasure":"Days"}