{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.8","upperLimit":"6.9","value":"5.4"},{"groupId":"OG001","lowerLimit":"6.9","upperLimit":"16.7","value":"10.2"},{"groupId":"OG002","lowerLimit":"7.0","upperLimit":"14.5","value":"10.8"},{"groupId":"OG003","lowerLimit":"3.0","upperLimit":"18.7","value":"11.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"18"}],"units":"Participants"}],"description":"Progression Free Survival (PFS) was defined as the time from study treatment start date to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants who have relapsed or progressed after receiving at least one line of prior anti-cancer therapy for metastatic disease received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.","id":"OG000","title":"Cohort A (Dabrafenib Monotherapy)"},{"description":"Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.","id":"OG001","title":"Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD"},{"description":"Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.","id":"OG002","title":"Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD"},{"description":"Crossover - Double Combination (Dabrafenib+Trametinib): Participants received Dabrafenib 150 mg BID in combination with Trametinib 2 mg once daily and continued treatment until disease progression, death, or unacceptable adverse event.","id":"OG003","title":"Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD"}],"paramType":"MEDIAN","populationDescription":"All Treated Population (ATP). Only participants with an evaluable PFS events were included in the analysis.","reportingStatus":"POSTED","timeFrame":"From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 113 months","title":"Progression Free Survival (PFS) Based on Local Investigator Assessment","type":"SECONDARY","unitOfMeasure":"Months"}