{"groups":[{"description":"Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.","id":"FG000","title":"Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID"},{"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":"FG001","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":"FG002","title":"Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"}],"type":"Study closed/terminated"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"84"},{"groupId":"FG001","numSubjects":"57"},{"comment":"includes 34 subjects from Cohort C and 2 subjects enrolled as protocol deviations from Cohort B.","groupId":"FG002","numSubjects":"36"}],"comment":"All participants who received at least one dose of study treatment were included in the All Treated Population (ATP)","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"57"},{"groupId":"FG002","numSubjects":"0"}],"comment":"All Treated Population who had relapsed or progressed after receiving at least one line of prior anti-cancer therapy for metastatic disease.","type":"2nd Line Plus All Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"34"}],"comment":"All Treated Population who had not received any prior anti-cancer therapy for metastatic disease.","type":"1st Line All Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"comment":"All Treated Population who were assigned to monotherapy cohort and elected to crossover to combination treatment following disease progression on monotherapy.","type":"Crossover"},{"achievements":[{"groupId":"FG000","numSubjects":"70"},{"groupId":"FG001","numSubjects":"49"},{"groupId":"FG002","numSubjects":"27"}],"comment":"Study ended when progression of disease had occurred in all patients in Cohorts B and C, a minimum of 70% of subjects had died in each cohort, or five years had passed since the last subject's first dose, whichever came first.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"9"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"The study was conducted in 50 sites across 11 countries: Netherlands(2), United States(15), Germany(4), Spain(7), France(8), Italy(3), Taiwan(2), South Korea(3), United Kingdom(3), Japan(2), Norway(1)"}