{"analyses":[{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.86","estimateComment":"Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Noninferiority was tested with a noninferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.","nonInferiorityType":"NON_INFERIORITY","pValue":"<0.0001","pValueComment":"Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)","paramType":"Hazard Ratio (HR)","paramValue":"0.65","statisticalMethod":"Stratified Wald test"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0024","statisticalComment":"Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)","statisticalMethod":"Stratified Log-rank test"}],"classes":[{"categories":[{"measurements":[{"comment":"Insufficient number of participants with events to estimate median and upper 95% confidence limit.","groupId":"OG000","lowerLimit":"34.3","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"33.2","upperLimit":"44.3","value":"35.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"327"},{"groupId":"OG001","value":"325"}],"units":"Participants"}],"description":"PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.","id":"OG000","title":"Zanubrutinib"},{"description":"Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.","id":"OG001","title":"Ibrutinib"}],"paramType":"MEDIAN","populationDescription":"Intent To Treat Analysis Set","reportingStatus":"POSTED","timeFrame":"From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).","title":"Progression-free Survival Assessed by the Independent Review Committee","type":"SECONDARY","unitOfMeasure":"months"}