{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"10"}]}],"title":"AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"10"}]}],"title":"Treatment-related AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"6"}]}],"title":"SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"3"}]}],"title":"Treatment-related SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"title":"Fatal SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"1"}]}],"title":"AEs leading to discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"16"},{"groupId":"OG004","value":"8"}]}],"title":"AEs requiring dose interruptions"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"1"}]}],"title":"AEs requiring dose reductions"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"16"},{"groupId":"OG004","value":"8"}]}],"title":"AEs requiring dose reductions or interruptions"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"10"}],"units":"Participants"}],"description":"Incidence of treatment emergent adverse events is defined as number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes from baseline in vital signs and laboratory results qualifying and reported as AEs. The number of participants in each category is reported in the table.","groups":[{"description":"Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \\<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)","id":"OG000","title":"Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D"},{"description":"Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \\<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)","id":"OG001","title":"Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D"},{"description":"Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)","id":"OG002","title":"Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D"},{"description":"Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \\< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \\<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)","id":"OG003","title":"Part D - LGG"},{"description":"Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \\< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \\<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)","id":"OG004","title":"Part D - LCH"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All subjects who received at least one dose of any component of the combination in Part C and Part D","reportingStatus":"POSTED","timeFrame":"From the day of the first dose of the combination up to 30 days after the last dose, up to maximum duration of 53 months","title":"Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib in Combination With Dabrafenib","type":"SECONDARY","unitOfMeasure":"Participants"}