{"analyses":[{"ciLowerLimit":"0.21","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.06","groupDescription":"The test to compare overall survival between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0577","paramType":"Hazard Ratio (HR)","paramValue":"0.47","statisticalComment":"Stratified by randomization stratification factors as recorded in IXRS","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.28","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.27","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1556","paramType":"Hazard Ratio (HR)","paramValue":"0.60","statisticalComment":"Stratified by randomization stratification factors as recorded in IXRS","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The median and corresponding 95% CI for the OS in Arm A was not reached due to insufficient subjects with events (Range of OS =1.7 to 40.4+ months).\n\n\"+\" indicates a value from a censored subject.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The median and corresponding 95% CI for the OS in Arm B was not reached due to insufficient subjects with events (Range of OS =0.1+ to 40.8+ months).\n\n\"+\" indicates a value from a censored subject.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The median and corresponding 95% CI for the OS in Arm C was not reached due to insufficient subjects with events. (Range of OS = 0.0+ to 40.7+ months) \"+\" indicates a value from a censored subject.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"177"},{"groupId":"OG001","value":"179"},{"groupId":"OG002","value":"179"}],"units":"Participants"}],"description":"OS was defined as the time from the date of randomization to death due to any cause.","dispersionType":"95% Confidence Interval","groups":[{"description":"Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.","id":"OG000","title":"Arm A: Obinutuzumab in Combination With Chlorambucil"},{"description":"Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.","id":"OG001","title":"Arm B: Acalabrutinib in Combination With Obinutuzumab"},{"description":"Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib","id":"OG002","title":"Arm C: Acalabrutinib Monotherapy"}],"paramType":"MEDIAN","populationDescription":"Intent to Treat (ITT)","reportingStatus":"POSTED","timeFrame":"From randomization date until death, withdrawal by subject, lost to follow-up, or by analysis data cut off date on 08Feb2019 whichever comes first up to 40 months of follow-up.","title":"Overall Survival (OS) in Arm A Versus Arm B and Arm A Versus Arm C","type":"SECONDARY","unitOfMeasure":"Months"}