{"analyses":[{"ciLowerLimit":"0.183","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.286","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.229","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Here, NA indicates upper limit of confidence interval (CI) was not estimable due to insufficient number of events.","groupId":"OG000","lowerLimit":"55.43","upperLimit":"NA","value":"65.12"},{"groupId":"OG001","lowerLimit":"13.86","upperLimit":"16.62","value":"14.32"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"289"},{"groupId":"OG001","value":"289"}],"units":"Participants"}],"description":"PFS was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. IWCLL 2008 criteria for PD: New enlarged nodes \\>1.5 cm, new hepatomegaly or splenomegaly, or other new organ infiltrates, bone lesion, ascites, or pleural effusion confirmed due to chronic lymphocytic leukemia (CLL); \\>=50% increase in existing lymph nodes; \\>=50% increase in enlargement of liver or spleen; \\>=50% increase from baseline in lymphocyte count (and to \\>=5\\*10\\^9/L) or \\>=50% increase from nadir count confirmed on \\>=2 serial assessments if absolute lymphocyte count (ALC) \\>=30,000 per microliter and lymphocyte doubling time is rapid, unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b \\[Hgb\\] or platelets) attributable to CLL; and transformation to a more aggressive histology.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received ibrutinib 420 milligram (mg) (3 \\* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.","id":"OG000","title":"Ibrutinib+BR"},{"description":"Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.","id":"OG001","title":"Placebo+BR"}],"paramType":"MEDIAN","populationDescription":"Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.","reportingStatus":"POSTED","timeFrame":"Up to 5 years","title":"Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"Months"}