{"analyses":[{"ciLowerLimit":"8.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"22.3","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Risk Difference (RD)","paramValue":"15.3","statisticalComment":"Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"-1.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"14.9","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0763","paramType":"Risk Difference (RD)","paramValue":"6.9","statisticalComment":"Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"71.9","upperLimit":"83.9","value":"78.5"},{"groupId":"OG001","lowerLimit":"89.3","upperLimit":"96.5","value":"93.9"},{"groupId":"OG002","lowerLimit":"79.6","upperLimit":"89.9","value":"85.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"177"},{"groupId":"OG001","value":"179"},{"groupId":"OG002","value":"179"}],"units":"Participants"}],"description":"ORR was defined as the proportion of subjects who achieved a best response of CR, CRi, nPR, or PR at or before initiation of subsequent anticancer therapy. ORR including PRL was defined as the proportion of subjects who achieved a best response of CR, CRi, nPR, PR or PRL at or before initiation of subsequent anticancer therapy","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":"NUMBER","populationDescription":"Intent to Treat","reportingStatus":"POSTED","timeFrame":"IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.","title":"IRC-assessed Objective Response Rate (ORR) in Arm A Versus Arm B and Arm A Versus Arm C","type":"SECONDARY","unitOfMeasure":"percentage of participants"}