{"analyses":[{"ciLowerLimit":"0.049","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.212","estimateComment":"Hazard ratio is estimated using a stratified Cox regression model.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.0001","pValueComment":"P-value is from a stratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.102","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"77.2","upperLimit":"93.3","value":"87.4"},{"groupId":"OG001","lowerLimit":"18.2","upperLimit":"41.6","value":"29.4"},{"groupId":"OG002","lowerLimit":"44.1","upperLimit":"79.2","value":"64.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"31"}],"units":"Participants"}],"description":"TTnT was measured from the date of randomization to the start date of any subsequent WM treatment. Participants without subsequent treatment were censored at the date of the last study visit.\n\nAs the median TTnT was not reached in the Ibrutinib + Rituximab arm and the Open-Label Substudy arm at the time of the analysis, Kaplan Meier landmark estimate of the TTnT rate at 54 months (that is, the estimated percentage of participants not receiving subsequent WM treatment 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":"Time to Next Treatment (TnT) Time From the Date of Randomization to the Start Date of Any Subsequent WM Treatment.","type":"SECONDARY","unitOfMeasure":"percentage of participants"}