{"analyses":[{"ciLowerLimit":"0.22","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.56","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","paramType":"Hazard Ratio (HR)","paramValue":"0.35","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.86","upperLimit":"0.93","value":"0.894"},{"groupId":"OG001","lowerLimit":"0.653","upperLimit":"0.813","value":"0.729"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"354"},{"groupId":"OG001","value":"175"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to CLL progression or death, whichever occurred first. Progression is characterized by any of the following:\n\n* ≥ 50% increase from nadir since start of treatment (tx) in the sum of the products of at least 2 lymph nodes on 2 consecutive examinations 2 weeks apart\n* ≥ 50% increase from nadir since start of tx in the size of liver and/or spleen\n* ≥ 50% increase in the absolute number of circulating lymphocytes not due to tumor flare reaction. The absolute lymphocyte count must be ≥ 5x10\\^9/L to qualify as disease progression.\n* Transformation to a more aggressive histology (e.g. Richter's syndrome or prolymphocytic leukemia with \\> 55% prolymphocytes). For patients who achieve a complete response or nodular partial response, progression is defined as recurrence of circulating leukemia cell clone in the peripheral blood and an absolute lymphocyte count \\> 5x10\\^9/L and/or recurrence of palpable lymphadenopathy \\> 1.5 cm by physical exam.","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 up to 4 years and 8 months","title":"Progression-free Survival (PFS) Rate at 3 Years","type":"PRIMARY","unitOfMeasure":"Proportion of participants"}