{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"2"},{"groupId":"OG011","value":"2"},{"groupId":"OG012","value":"3"}],"title":"Complete response (CR)"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"2"},{"groupId":"OG011","value":"9"},{"groupId":"OG012","value":"3"}],"title":"Partial response (PR)"},{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"8"},{"groupId":"OG007","value":"4"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"5"},{"groupId":"OG010","value":"1"},{"groupId":"OG011","value":"8"},{"groupId":"OG012","value":"3"}],"title":"Stable disease (SD)"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"}],"title":"Progressive disease (PD)"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"}],"title":"Non-CR/Non-PD"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"0"}],"title":"Unknown"},{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"1"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"1"}],"title":"Missing"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"16"},{"groupId":"OG004","value":"11"},{"groupId":"OG005","value":"10"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"10"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"9"},{"groupId":"OG010","value":"6"},{"groupId":"OG011","value":"20"},{"groupId":"OG012","value":"10"}],"units":"Participants"}],"description":"Response evaluations were assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for subjects with solid tumors except neuroblastomas, primary central nervous system tumors (gliomas) or plexiform neurofibromas (PNs).\n\nResponse evaluations for subjects with neuroblastomas could have included: measureable disease (by CT/MRI alone) assessed according to RECIST v1.1, evaluable disease assessed for meta-iodobenzylguanidine (MIBG) response, and biochemical (urine HVA/VMA) with bone marrow involvement assessed by Hematoxylin and Eosin staining of bilateral bone marrow biopsies and aspirates.\n\nResponse evaluations for glioma subjects was assessed using Response Assessment in Neuro Oncology (RANO) criteria with solid tumors through MRI scans.\n\nResponse evaluations of PNs were assessed using volumetric determination and Dombi criteria through MRI scans.\n\nThe number of participants in each response category is reported in the table.","groups":[{"description":"Participants treated with trametinib 0.0125 mg/kg/day","id":"OG000","title":"Part A - TMT 0.0125 mg/kg/Day"},{"description":"Participants treated with trametinib 0.025 mg/kg/day","id":"OG001","title":"Part A - TMT 0.025 mg/kg/Day"},{"description":"Participants under 6 years of age treated with trametinib 0.032 mg/kg/day","id":"OG002","title":"Part A - TMT 0.032 mg/kg/Day"},{"description":"Participants treated with trametinib 0.04 mg/kg/day","id":"OG003","title":"Part A - TMT 0.04 mg/kg/Day"},{"description":"Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day","id":"OG004","title":"Part B - Neuroblastoma"},{"description":"Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day","id":"OG005","title":"Part B - LGG Fusion"},{"description":"Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day","id":"OG006","title":"Part B - NF-1 With PN"},{"description":"Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day","id":"OG007","title":"Part B - BRAF V600 Mutant Solid Tumor"},{"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":"OG008","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":"OG009","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":"OG010","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":"OG011","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":"OG012","title":"Part D - LCH"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All subjects who received at least one dose of trametinib in Part A and Part B or 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 any study drug up to the last dose, up to maximum duration of 63 months","title":"Best Overall Response (BOR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment","type":"SECONDARY","unitOfMeasure":"Participants"}