{"analyses":[{"ciLowerLimit":"0.328","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.99","estimateComment":"Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.","groupDescription":"Data cutoff 18 December 2019","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.643","pValueComment":"P-value is from unstratified log rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.808","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"73.7","upperLimit":"93.3","value":"86.4"},{"groupId":"OG001","lowerLimit":"71.3","upperLimit":"91.6","value":"84.2"},{"groupId":"OG002","lowerLimit":"53.7","upperLimit":"85.7","value":"73.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"31"}],"units":"Participants"}],"description":"OS, defined as the time from the date of randomization to the date of death from any cause. All deaths observed as the time of the analysis were considered as events. For participants who were not known to have died at the time of the analysis, OS data were censored at the date last known alive.\n\nAs the median OS was not reached in any treatment arm at the time of the analysis, Kaplan Meier point estimates of the OS rate (that is, the estimated percentage of participants still surviving at Month 54) are presented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.\n\nRituximab: 375 mg/m\\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.","id":"OG000","title":"Ibrutinib + Rituximab"},{"description":"Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.\n\nRituximab: 375 mg/m\\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.","id":"OG001","title":"Placebo + Rituximab"},{"description":"Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.","id":"OG002","title":"Open-Label Substudy: Ibrutinib"}],"paramType":"NUMBER","populationDescription":"Intent to Treat population: all randomized/enrolled participants","reportingStatus":"POSTED","timeFrame":"Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr])","title":"Overall Survival (OS) - Kaplan Meier Landmark Estimates at Month 54","type":"SECONDARY","unitOfMeasure":"percentage of participants"}