{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"13"}]}],"title":"ORR 3rd IWWM criteria (CR+VGPR+PR+MR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"CR (IWWM 3rd criteria)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"1"}]}],"title":"VGPR (IWWM 3rd criteria)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"10"}]}],"title":"PR (IWWM 3rd criteria)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"2"}]}],"title":"MR (IWWM 3rd criteria)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"description":"ORR defined as the rate of subjects achieving a Miner Response (MR) or better including complete response (CR), very good partial response (VGPR), partial response (PR) and MR; The definition of responses are evaluated by investigators using both Modified 6th criteria (refer to protocol table 4-2 , 4-3) and Modified 3rd International Workshop of Waldenström Macroglobulinemia (IWWM) criteria (refer to protocol table 4-4 and table 4-5 for definition). For Modified 6th criteria, MR is defined as (1) monoclonal IgM protein is detectable, (2) no new signs or symptoms of active disease, (3) and patient has \\>=25% but \\< 50% reduction in serum monoclonal IgM level from baseline. PR and VGPR both require (1) and (2) as MR, but PR also requires the \\>=50% and \\<90% reduction in serum monoclonal IgM level as well as reduction in extramedullary disease. VGPR requires \\>= 90% reduction in serum IgM and complete resolution of extramedullary disease.","groups":[{"description":"100 mg BID N=92","id":"OG000","title":"Previously Treated (N=92)"},{"description":"100 mg BID N= 14","id":"OG001","title":"Treatment Naive (N=14)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"In the original protocol, previously treated subjects were planned to be randomized 1:1 into 2 cohorts: Cohort 1 to receive Acala 100 mg BID for 28 days and Cohort 2 to receive Acala 200 mg once daily (QD) for 28 days. After enrollment started, the dose regimen was amended. The 200 mg QD dose was eliminated, and subjects who were enrolled under the original protocol and received treatment with 200 mg QD were switched to 100 mg BID. Results are combined.","reportingStatus":"POSTED","timeFrame":"Up to approximately 3.8 years. Data cut at when last patient has completed Cycle 27 (28 days per Cycle).","title":"Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 3rd Criteria","type":"PRIMARY","unitOfMeasure":"Participants"}