{"analyses":[{"ciLowerLimit":"2.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"22.4","groupIds":["OG000","OG001"],"nonInferiorityComment":"one-sided p-value at 2.5% level of significance","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","paramType":"Odds Ratio (OR)","paramValue":"7.19","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"34.8","upperLimit":"58.6","value":"46.6"},{"groupId":"OG001","lowerLimit":"3.0","upperLimit":"25.4","value":"10.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"37"}],"units":"Participants"}],"description":"Percentage of participants in the LGG cohort with a best overall confirmed Complete Response (CR) or Partial Response (PR) as assessed per RANO criteria by central independent assessment. The 95% confidence intervals (CIs) were computed using two-sided exact binomial method.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.","reportingStatus":"POSTED","timeFrame":"Up to approximately (approx.) 3 years","title":"LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using Response Assessment in Neuro-Oncology (RANO) Criteria","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}