{"analyses":[{"ciLowerLimit":"0.20","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.49","estimateComment":"Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<0.0001","pValueComment":"Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).","paramType":"Hazard Ratio (HR)","paramValue":"0.31","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Kaplan-Meier Estimated Median PFS and 95% were not reached for Arm A.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"14.0","upperLimit":"17.1","value":"16.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"155"}],"units":"Participants"}],"description":"To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012) hereafter referred to as IWCLL 2008 criteria in subjects with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). As planned and reported in the interim clinical study report (dated 17 July 2019), because the study did cross the boundary at interim analysis.\n\nIRC assessments were discontinued after the interim analysis. All IRC-related efficacy analyses in this clinical study report were based on the interim analysis data cutoff date of 15 January 2019. All other efficacy analyses were based on the final analysis data cutoff date of 03 September 2021.","dispersionType":"95% Confidence Interval","groups":[{"description":"Acalabrutinib 100 mg orally twice a day","id":"OG000","title":"Arm A: Acalabrutinib Monotherapy"},{"description":"Idelalisib+Rituximab or Bendamustine + Retuximab","id":"OG001","title":"Arm B: Investigators Choice"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat population including all randomized participants","reportingStatus":"POSTED","timeFrame":"IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up","title":"Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment","type":"PRIMARY","unitOfMeasure":"Months"}