{"analyses":[{"ciLowerLimit":"0.05","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.54","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","paramType":"Hazard Ratio (HR)","paramValue":"0.17","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.976","upperLimit":"1.00","value":"0.988"},{"groupId":"OG001","lowerLimit":"0.862","upperLimit":"0.970","value":"0.915"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"354"},{"groupId":"OG001","value":"175"}],"units":"Participants"}],"description":"Overall survival was defined as time from randomization to death from any cause or date last known alive. Overall survival rate at 3 years was estimated using the method of Kaplan-Meier.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.","id":"OG000","title":"Arm A (Ibrutinib, Rituximab)"},{"description":"Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.","id":"OG001","title":"Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)"}],"paramType":"NUMBER","populationDescription":"All randomized patients were included in this analysis.","reportingStatus":"POSTED","timeFrame":"Assessed every 3 months until progression; after progression, assessed every 3 months for first 2 years, every 6 months for years 3-5, up to 4 years and 8 months","title":"Overall Survival (OS) Rate at 3 Years","type":"SECONDARY","unitOfMeasure":"Proportion of participants"}