{"analyses":[{"groupDescription":"Statistical test on binomial proportion of ORR against a null hypothesis of 28%, one sided alpha=0.025.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.0001","statisticalMethod":"Wald Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"62.7","upperLimit":"82.6","value":"73.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"83"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants with a confirmed best response of complete remission (CR), complete remission with partial recovery of peripheral blood counts (CRh), partial remission (PR), or clinical improvement (CI) by mIWG-MRT-ECNM criteria. The mIWG-MRT-ECNM criteria were based on findings from bone marrow biopsy and aspirate, and peripheral blood smear; bone marrow cytogenetics; other extracutaneous tissue biopsies (when available); liver and spleen imaging; and other clinical and laboratory parameters.","dispersionType":"95% Confidence Interval","groups":[{"description":"Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.","id":"OG000","title":"Avapritinib"}],"paramType":"NUMBER","populationDescription":"Response-evaluable Population: all participants who received ≥1 dose of avapritinib, were deemed evaluable per mIWG-MRT-ECNM criteria at baseline as assessed by study steering committee review and had 1 of the following conditions: ≥2 complete postbaseline bone marrow assessments and had been on study for ≥6 cycles; had an end of study visit.","reportingStatus":"POSTED","timeFrame":"Baseline through Month 65","title":"Overall Response Rate (ORR) Based on Modified International Working Group-Myeloproliferative Neoplasms Research and Treatment and European Competence Network on Mastocytosis (mIWG-MRT-ECNM) Response Criteria","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}