{"analyses":[{"ciLowerLimit":"0.973","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.247","estimateComment":"For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1279","pValueComment":"Estimate and p-value for rate ratio are based on CMH test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \\>=3) and TLS category (low risk vs increased risk) at randomization.","paramType":"Rate Ratio","paramValue":"1.101","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"74.5","upperLimit":"88.2","value":"82.1"},{"groupId":"OG001","lowerLimit":"66.2","upperLimit":"81.6","value":"74.4"},{"groupId":"OG002","lowerLimit":"87.4","upperLimit":"98.6","value":"94.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"133"},{"groupId":"OG002","value":"78"}],"units":"Participants"}],"description":"ORR is defined as the percentage of participants with CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.","id":"OG000","title":"Randomization Phase: Ibrutinb + Venetoclax"},{"description":"Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.","id":"OG001","title":"Randomization Phase: Ibrutinib + Placebo"},{"description":"Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).","id":"OG002","title":"Treatment-naive Open-label Arm"}],"paramType":"NUMBER","populationDescription":"All randomized participants and all treatment-naive open-label arm participants.","reportingStatus":"POSTED","timeFrame":"For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)","title":"Overall Response Rate (ORR) (Randomization Phase and Treatment-Naive Arm)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}