{"analyses":[{"groupDescription":"Zanubrutinib versus historical control estimate of 30%","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"P value was based on the exact binomial test against the null hypothesis H0: MRR = 0.30 at a significance level of 0.025 (1-sided)","statisticalMethod":"Exact binomial test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"53.87","upperLimit":"82.82","value":"69.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"}],"units":"Participants"}],"description":"MRR is defined as the percentage of participants who achieved complete response (CR) + very good partial response (VGPR) + partial response (PR), as assessed by an independent review committee according to modified Owen's criteria","dispersionType":"95% Confidence Interval","groups":[{"description":"Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity","id":"OG000","title":"Zanubrutinib"}],"paramType":"NUMBER","populationDescription":"Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L","reportingStatus":"POSTED","timeFrame":"Up to approximately 1 year and 9 months","title":"Major Response Rate (MRR) as Assessed by the Independent Review Committee","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}