{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0112","statisticalComment":"The ORR will be compared at the end of Cycle 16 between selumetinib vs placebo with the 2-sided significance level 0.047.","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.2","upperLimit":"30.9","value":"19.7"},{"groupId":"OG001","lowerLimit":"1.5","upperLimit":"13.3","value":"5.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"74"}],"units":"Participants"}],"description":"Objective response rate is defined as the proportion of participants who have a confirmed CR (defined as disappearance of the target PN, confirmed by a consecutive scan within 3 to 6 months after the first response) or confirmed PR (defined as a target PN volume decrease ≥ 20%, compared to baseline, confirmed by a consecutive scan within 3 to 6 months after the first response) by end of Cycle 16 as determined by ICR per REiNS criteria.\n\nIncrease in the volume of the target PN by 20% or more compared to baseline or the time of best response after documenting a PR is considered as PD.","dispersionType":"95% Confidence Interval","groups":[{"description":"Actual Treatment Group","id":"OG000","title":"Selumetinib 25 mg/m2"},{"description":"Actual Treatment Group","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"Full analysis set - All patients who are randomized to study intervention","reportingStatus":"POSTED","timeFrame":"From first dose up until progression (if it occurs prior to the end of Cycle 16), or the last evaluable assessment up to and including the end of Cycle 16, excluding MRI during prolonged study intervention interruption (defined as interruption >= 28 days)","title":"Confirmed Partial and Complete Response Rate (ORR) by End of Cycle 16 Using Volumetric MRI Analysis as Determined by ICR (Per REiNS Criteria) in Participants With NF1 Who Have Symptomatic, Inoperable PN.","type":"PRIMARY","unitOfMeasure":"Percentage"}