{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.7","upperLimit":"81.3","value":"50.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"}],"units":"Participants"}],"description":"Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed accounting for the two-stage design. A responder is defined as a patient who achieves a best response of PR or CR on the study prior to having an overall response of PD; all others will be considered non-responders. The definitions of response are based on a publication (PMID: 25552679) entitled \"Criteria for evaluating response and outcome in clinical trials for children with juvenile myelomonocytic leukemia\". Patients can be categorized as having experienced complete remission, partial remission, stable disease, or progressive disease based on a combination of clinical and molecular variables.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive trametinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a bone marrow aspiration or biopsy at baseline, on day 28 of cycles 1 and 2, at all subsequent odd numbered cycles, and at end of treatment.","id":"OG000","title":"Treatment (Trametinib)"}],"paramType":"NUMBER","populationDescription":"All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1521 protocol.","reportingStatus":"POSTED","timeFrame":"12 cycles (1 cycle = 28 days)","title":"Objective Response","type":"PRIMARY","unitOfMeasure":"Percentage of patients"}