{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.068","value":"42.67"},{"groupId":"OG001","spread":"10.502","value":"42.89"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.439","value":"42.14"},{"groupId":"OG001","spread":"10.109","value":"39.06"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"Week 5 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.461","value":"43.83"},{"groupId":"OG001","spread":"7.759","value":"38.36"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"Week 8 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.159","value":"44.68"},{"groupId":"OG001","spread":"10.798","value":"41.11"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"10"}],"units":"Participants"}],"title":"Week 16 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.168","value":"45.27"},{"groupId":"OG001","spread":"6.241","value":"36.57"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"10"}],"units":"Participants"}],"title":"Week 24 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.887","value":"45.46"},{"groupId":"OG001","spread":"7.159","value":"40.96"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Week 32 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.687","value":"45.37"},{"groupId":"OG001","spread":"4.960","value":"38.84"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"title":"Week 40 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.421","value":"44.83"},{"groupId":"OG001","spread":"6.953","value":"41.56"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"10"}],"units":"Participants"}],"title":"Week 48 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.876","value":"44.54"},{"groupId":"OG001","spread":"8.851","value":"38.66"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"title":"Week 56 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.967","value":"44.21"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Week 72 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.847","value":"44.91"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Week 88 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.231","value":"45.60"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Week 104 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.317","value":"44.41"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Week 120 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.074","value":"44.45"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Week 136 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.534","value":"47.88"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Week 152 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.888","value":"46.48"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Week 168 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.274","value":"44.98"},{"groupId":"OG001","spread":"10.536","value":"39.69"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"title":"EOT"},{"categories":[{"measurements":[{"groupId":"OG000","value":"45.40"},{"groupId":"OG001","spread":"6.288","value":"45.53"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"}],"units":"Participants"}],"title":"Post Treatment Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27.70"},{"groupId":"OG001","value":"39.70"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Post Treatment Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"43.60"},{"groupId":"OG001","value":"34.60"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Post Treatment Follow-Up 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"31.20"},{"groupId":"OG001","spread":"8.061","value":"43.60"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Post Treatment Follow-Up 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29.40"},{"groupId":"OG001","value":"37.90"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Post Treatment Follow-Up 5"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"7.425","value":"36.45"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Post Treatment Follow-Up 6"},{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Post Treatment Follow-Up 7"},{"categories":[{"measurements":[{"groupId":"OG001","value":"37.90"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Post Treatment Follow-Up 8"}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"description":"The PROMIS Parent Proxy Global Health 7+2 was used to evaluate the quality of life of participants. The questionnaire included 7 items measuring the global health of the patient. 4 items used a 5-level Likert scale with 1=poor and 5=excellent; 1 item used a 5-level Likert scale with 1=never and 5=always; and 2 items used a 5-level Likert scale with 1=never and 5=almost always. The total raw global health score, ranging from 7 to 35, was computed by summing item values, with higher scores indicating better overall well-being. Raw scores were then transformed into T-scores, standardized with a mean of 50 and a standard deviation of 10. Higher T-scores reflected better global health status.\n\nParticipants who discontinued treatment for reasons other than disease progression entered the post-treatment efficacy follow-up phase, where the questionnaire was performed every 16 weeks until disease progression, withdrawal of consent by patient or a parental/legal guardian, or lost to follow-up.","dispersionType":"Standard Deviation","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":"OG000","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":"OG001","title":"LGG Cohort: Carboplatin and Vincristine"}],"paramType":"MEAN","populationDescription":"All participants on the LGG cohort to whom study treatment had been assigned by randomization (regardless of whether or not treatment was administered) and contributed to this analysis. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.\n\nNumber analyzed indicated number of participants with available data for this outcome measure at the specified timepoints.","reportingStatus":"POSTED","timeFrame":"Baseline, and Day 1 of Week 5, 8, 16, 24, 32, 49, 48 and 56, and thereafter every 16 weeks until end of treatment (EOT), EOT, and every 16 weeks in the post-treatment efficacy follow-up phase until disease progression (assessed up to 4.6 years)","title":"LGG Cohort: PROMIS Parent Proxy Global Health 7+2 Scores- Global Health Score","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}