{"analyses":[{"ciLowerLimit":"0.17","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.29","estimateComment":"Hazard ratio was estimated by Cox regression model.","groupDescription":"Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.22","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.19","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.31","estimateComment":"Hazard ratio was estimated by Cox regression model.","groupDescription":"Unstratified Analysis","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.25","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.2","upperLimit":"21.0","value":"16.4"},{"groupId":"OG001","lowerLimit":"48.5","upperLimit":"59.3","value":"53.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"194"}],"units":"Participants"}],"description":"EFS was defined as the time from date of randomization until the date of PD/relapse, start of a new non-protocol-specified anti-CLL therapy, or death from any cause, whichever occurred first, as assessed by the investigator. PD: occurrence of one of the following: new lesion; new palpable lymph node (\\>1.5 cm); unequivocal progression of non-target lesion; increase of \\>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \\>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \\>/=50% in platelet or neutrophil count, or hemoglobin level by \\>2 g/dL or to \\<10 g/dL. Participants without any of the specified event at the time of analysis were censored at the date of last adequate response assessment. In case of no post-baseline response assessment, participants were censored at the randomization date. The median EFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\\^2 on Day 1 of Cycles 2-6.","id":"OG000","title":"Bendamustine + Rituximab Main Study"},{"description":"Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\\^2 on Day 1 of Cycles 2-6.","id":"OG001","title":"Venetoclax + Rituximab Main Study"}],"paramType":"MEDIAN","populationDescription":"ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.","reportingStatus":"POSTED","timeFrame":"Baseline up to PD/relapse, start of a new anti-CLL therapy, or death from any cause, whichever occurred first (approximately 8 years 5 months)","title":"Event-Free Survival (EFS) as Assessed by the Investigator Using iwCLL Guidelines","type":"SECONDARY","unitOfMeasure":"months"}