{"analyses":[{"ciLowerLimit":"0.148","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.420","estimateComment":"The hazard ratio and its 95% confidence interval were based on a Cox regression model stratified by the randomization stratification factors.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.0001","pValueComment":"The treatment effect was tested with a stratified log rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.250","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"54.8","upperLimit":"78.1","value":"68.0"},{"groupId":"OG001","lowerLimit":"15.3","upperLimit":"36.6","value":"25.3"},{"groupId":"OG002","lowerLimit":"22.3","upperLimit":"56.7","value":"39.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"31"}],"units":"Participants"}],"description":"PFS was defined as the time from date randomization to date of first IRC-confirmed disease progression (PD) assessed according to the modified VIth International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria (National Comprehensive Cancer Network \\[NCCN\\] 2014) or death due to any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death.\n\nAs the median PFS was not reached in the Ibrutinib + Rituximab arm at the time of the analysis, Kaplan Meier landmark estimate of the PFS rate at 54 months (that is, the estimated percentage of participants with PFS at Month 54) is 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":"Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54","type":"PRIMARY","unitOfMeasure":"percentage of participants"}