{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.4","upperLimit":"99.2","value":"67"}]}],"title":"Investigator assessment @ up to 78 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.4","upperLimit":"99.2","value":"67"}]}],"title":"Investigator assessment @ up to 92 months"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"}],"units":"Participants"}],"description":"Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \\[CR\\], partial response \\[PR\\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.","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":"Adenocarcinoma of the Small Intestine (ASI)"}],"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 Adenocarcinoma of the Small Intestine (ASI) Cohort","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}