{"groups":[{"description":"Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.","id":"FG000","title":"Dabrafenib + Trametinib"},{"description":"Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.","id":"FG001","title":"Dabrafenib + Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"136"},{"groupId":"FG001","numSubjects":"146"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"9"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}],"type":"Investigator discretion"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"4"}],"type":"Withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"23"}],"type":"Study closed/terminated"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"28"}],"type":"Crossover to Dabrafenib + Trametinib"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"211"},{"groupId":"FG001","numSubjects":"212"}],"comment":"All randomized patients included into Intent-to-Treat (ITT) population.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"209"},{"groupId":"FG001","numSubjects":"211"}],"comment":"All patients who received at least one dose of study treatment","type":"Safety Set"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"28"}],"comment":"All monotherapy randomized patients who crossed over to combination therapy","type":"Crossover Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"211"},{"groupId":"FG001","numSubjects":"212"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Approximately, 340 subjects were planned to be randomized in a 1:1 ratio (170 subjects each in combination therapy and monotherapy). A total of 423 subjects with unresectable or metastatic, BRAF V600E or V600K mutation-positive melanoma were randomized to dabrafenib and trametinib (n=211) or dabrafenib and placebo (n=212).","recruitmentDetails":"This study was conducted in 103 centers in 14 countries worldwide: Argentina (1), Australia (6), Canada (5), France (8), Germany (25), Greece (3), Italy (8), Netherlands (3), Russia (4), Spain (7), Sweden (4), Ukraine (7), United Kingdom (10), and USA (12)."}