{"analyses":[{"ciLowerLimit":"1.05","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.22","estimateComment":"Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.","nonInferiorityType":"NON_INFERIORITY","pValue":"<0.0001","paramType":"Response ratio","paramValue":"1.14","statisticalComment":"Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)","statisticalMethod":"Stratified Wald test"},{"groupIds":["OG000","OG001"],"nonInferiorityComment":"Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.","nonInferiorityType":"SUPERIORITY","pValue":"0.0007","statisticalComment":"Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"82.0","upperLimit":"89.8","value":"86.2"},{"groupId":"OG001","lowerLimit":"70.7","upperLimit":"80.3","value":"75.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"327"},{"groupId":"OG001","value":"325"}],"units":"Participants"}],"description":"ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) assessed by a blinded independent review committee. Overall response was assessed by the IRC for the purpose of regulatory filing with the Food and Drug Administration (FDA).\n\nDisease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL.","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":"NUMBER","populationDescription":"ITT 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":"ORR Assessed by the Independent Review Committee (IRC)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}