{"analyses":[{"ciLowerLimit":"0.09","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.49","estimateComment":"Hazard ratio was estimated by Cox regression model.","groupDescription":"Stratified Analysis; Stratification factor: geographic region.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.21","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.09","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.46","estimateComment":"Hazard ratio was estimated by Cox regression model.","groupDescription":"Unstratified Analysis","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.21","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.6","upperLimit":"22.3","value":"16.1"},{"comment":"Median and Upper Limit of 95% CI could not be estimated due to low number of participants with an event.","groupId":"OG001","lowerLimit":"27.6","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"46"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC 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% CI was computed using method of Brookmeyer and Crowley. No new IRC data was generated post the primary analysis.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received bendamustine at a dose of 70 mg/m\\^2 via 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. Only participants with 17p deletion as identified by FISH test were included.","id":"OG000","title":"Bendamustine + Rituximab 17p Del. Population"},{"description":"Participants were initially placed on a venetoclax ramp-up period of 4 to 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet 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. Only participants with 17p deletion as identified by FISH test were included.","id":"OG001","title":"Venetoclax + Rituximab 17p Del. Population"}],"paramType":"MEDIAN","populationDescription":"Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.","reportingStatus":"POSTED","timeFrame":"Baseline up to PD or death, whichever occurred first (up to approximately 3 years)","title":"PFS as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test","type":"SECONDARY","unitOfMeasure":"months"}