{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"77.8","upperLimit":"95.9","value":"89"}]}],"title":"Investigator assessment @ up to 78 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"77.8","upperLimit":"95.9","value":"89"}]}],"title":"Investigator assessment @ up to 92 months"}],"denoms":[{"counts":[{"groupId":"OG000","value":"55"}],"units":"Participants"}],"description":"Overall Response Rate (ORR) was defined as the percentage of participants with CR +/- minimal residual disease \\[MRD\\], PR by investigator assessment as defined by the Consensus Resolution Criteria adapted from the National Comprehensive Cancer Network (NCCN) guidelines. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.","dispersionType":"95% Confidence Interval","groups":[{"description":"All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.","id":"OG000","title":"Hairy Cell Leukemia (HCL)"}],"paramType":"NUMBER","populationDescription":"ITT/Evaluable population - Primary and expansion cohort combined","reportingStatus":"POSTED","timeFrame":"From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)","title":"Overall Response Rate (ORR) in the Hairy Cell Leukemia (HCL) Cohort","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}