{"analyses":[{"ciLowerLimit":"0.31","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.69","estimateComment":"The hazard ratio was estimated from a stratified Cox regression model stratified by rituximab-refractory status, number of prior lines of therapy and geographic region.","groupDescription":"For Investigator Assessment","groupIds":["OG000","OG001"],"nonInferiorityComment":"The two-sided significance threshold was set at α = 0.05.","nonInferiorityType":"OTHER","pValue":"0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.47","statisticalComment":"The p-value was stratified by rituximab-refractory status, number of prior lines of therapy and geographic region.","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.32","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.81","estimateComment":"The hazard ratio was estimated from a stratified Cox regression model stratified by rituximab-refractory status, number of prior lines of therapy and geographic region.","groupDescription":"For ICR Assessment","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0040","paramType":"Hazard Ratio (HR)","paramValue":"0.51","statisticalComment":"The p-value was stratified by rituximab-refractory status, number of prior lines of therapy and geographic region.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.5","upperLimit":"15.7","value":"11.2"},{"comment":"Not estimable due to insufficient number of participants with events","groupId":"OG001","lowerLimit":"16.1","upperLimit":"NA","value":"27.4"}]}],"title":"ICR"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.7","upperLimit":"8.2","value":"5.8"},{"comment":"Not estimable due to insufficient number of participants with events","groupId":"OG001","lowerLimit":"11.3","upperLimit":"NA","value":"22.2"}]}],"title":"Investigator"}],"denoms":[{"counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the date of first documented disease progression or death from any cause, whichever occurred first, as determined by the ICR or investigator assessment. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the PFS calculation. Median PFS was estimated using the Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.","id":"OG000","title":"Obinutuzumab"},{"description":"Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.","id":"OG001","title":"Zanubrutinib + Obinutuzumab"}],"paramType":"MEDIAN","populationDescription":"ITT Analysis Set","reportingStatus":"POSTED","timeFrame":"From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.","title":"Progression-free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"Months"}