{"groups":[{"description":"Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)","id":"FG000","title":"LGG Cohort: Dabrafenib and Trametinib"},{"description":"Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.","id":"FG001","title":"LGG Cohort: Carboplatin and Vincristine"},{"description":"Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)","id":"FG002","title":"HGG Cohort: Dabrafenib and Trametinib"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"19"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"New therapy for study indication"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Subject/guardian decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"73"},{"groupId":"FG001","numSubjects":"37"},{"groupId":"FG002","numSubjects":"41"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"73"},{"groupId":"FG001","numSubjects":"33"},{"groupId":"FG002","numSubjects":"41"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"56"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"17"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"23"},{"groupId":"FG002","numSubjects":"24"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Subject/guardian decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"New therapy for study indication"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"22"},{"groupId":"FG002","numSubjects":"5"}],"comment":"Participants who discontinued study treatment for reasons other than disease progression, death, loss to follow up, or withdrawal of consent","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"2"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"3"}],"type":"NOT COMPLETED"}],"title":"Post-treatment Efficacy Follow-up"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"7"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lack of Efficacy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"9"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}],"comment":"Alive at the end of the study","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"7"}],"type":"NOT COMPLETED"}],"title":"Post-treatment Survival Follow-up"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Progressive disease"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Participants randomized to the carboplatin with vincristine treatment arm were allowed to cross-over to receive dabrafenib in combination with trametinib treatment after centrally confirmed and RANO-defined disease progression","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Crossover Treatment Period"}],"preAssignmentDetails":"Pediatric patients for both cohorts were screened for eligibility during the 28 days immediately prior to starting study treatment on Day 1.\n\nIn the LGG cohort, 121 patients were screened of whom 110 patients were randomized in a 2:1 ratio to the dabrafenib and trametinib arm or the carboplatin with vincristine arm. 4 participants randomized to chemotherapy arm were never treated.\n\nIn the HGG cohort, 46 patients were screened of whom 41 patients entered the HGG cohort","recruitmentDetails":"The study was conducted in 58 centers across 20 countries"}