{"analyses":[{"ciLowerLimit":"0.21","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.40","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":"Log Rank Test stratified by 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":"0.29","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Kaplan-Meier estimate of median TTNT and upper 95% CI were not reached.","groupId":"OG000","lowerLimit":"46.9","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"17.5","upperLimit":"25.9","value":"22.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"155"}],"units":"Participants"}],"description":"Time to Next Treatment (TTNT) is defined as the time from date of randomization to date of institution of non-protocol-specified treatment for CLL (or first dose date of acalabrutinib for Arm B subjects crossing over to receive acalabrutinib) or death due to any cause, whichever comes first.","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: Investigator's Choice"}],"paramType":"MEDIAN","populationDescription":"Intent to treat (ITT) population including all randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause or study discontinuation or data cutoff date on 03Sep2021,, whichever came first up to 53 months of follow-up.","title":"Time to Next Treatment (TTNT) Based on 03 September 2021 Data Cutoff","type":"SECONDARY","unitOfMeasure":"Months"}