{"analyses":[{"ciLowerLimit":"0.18","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.29","estimateComment":"Hazard ratio was estimated by Cox regression model.","groupDescription":"Stratified analysis: 17p deletion, risk status, geographic region.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.23","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":"15.5","upperLimit":"21.7","value":"17.0"},{"groupId":"OG001","lowerLimit":"52.3","upperLimit":"59.9","value":"54.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"194"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the investigator using iwCLL guidelines, or death from any cause, whichever occurred first. 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 who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% confidence interval (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 or death, whichever occurred first (up to approximately 8 years 5 months)","title":"Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines","type":"PRIMARY","unitOfMeasure":"months"}