{"groups":[{"description":"Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.","id":"FG000","title":"Dabrafenib Plus Trametinib"},{"description":"Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.","id":"FG001","title":"Vemurafenib"},{"description":"With Protocol Amendment 7, patients still receiving study treatment on the Vemurafenib monotherapy arm were allowed to cross over to the Dabrafenib and Trametinib combination arm.","id":"FG002","title":"Crossover Dabrafenib Plus Trametinib"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"217"},{"groupId":"FG001","numSubjects":"238"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"93"},{"groupId":"FG001","numSubjects":"39"},{"groupId":"FG002","numSubjects":"0"}],"type":"Sponsor Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"22"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"34"},{"groupId":"FG002","numSubjects":"0"}],"type":"Crossover to Dabrafenib&Trametinib"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"352"},{"groupId":"FG001","numSubjects":"352"},{"groupId":"FG002","numSubjects":"0"}],"comment":"All randomized patients included into Intent-to-Treat (ITT) population.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"350"},{"groupId":"FG001","numSubjects":"349"},{"groupId":"FG002","numSubjects":"0"}],"comment":"All patients who received at least one dose of study treatment","type":"Safety Set"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"comment":"ongoing status (incomplete end-of-study data and never received study treatment)","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"351"},{"groupId":"FG001","numSubjects":"352"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Randomized Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"11"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"20"}],"type":"Sponsor Decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"34"}],"comment":"All crossover randomized patients included into ITT \\& Safety Sets","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"34"}],"type":"NOT COMPLETED"}],"title":"Crossover Phase"}],"preAssignmentDetails":"694 subjects were planned and 704 subjects (352 each in combination therapy arm and vemurafenib monotherapy arm) were actually randomized and analyzed. Subjects were stratified by LDH level (\\> the ULN versus ≤ ULN) and BRAF mutation (V600E versus V600K).","recruitmentDetails":"This study was conducted at 207 centers in 28 countries worldwide (Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, South Korea, Netherlands, New Zealand, Norway, Poland, Russian Federation, Spain, Sweden,Switzerland, Taiwan, Ukraine, UK and USA)."}