{"analyses":[{"ciLowerLimit":"-1.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.41","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.070","paramType":"LS mean difference","paramValue":"-0.8","statisticalComment":"Analysis is based on a MMRM model for repeated measures, Kenward-Roger method is used to estimate the degrees of freedom.","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.30","value":"-2.0"},{"groupId":"OG001","spread":"0.29","value":"-1.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"42"}],"units":"Participants"}],"description":"The PAINS-pNF (Pain Intensity Scale for Plexiform Neurofibroma) chronic target PN pain intensity measures the participants' experience of chronic PN-related pain intensity with score from 0 (no chronic tumor pain) to 10 (worst chronic tumor pain). Baseline PAINS-pNF chronic target PN pain score is defined as the average of the available daily PAINS-pNF chronic target PN pain scores in the screening perio, while for Cycle 12, it is defined as the average of the available daily scores for the 28-days cycle up to and including the last day assessment of cycle 12. The difference of the means in the change from baseline at Cycle 12 between selumetinib and placebo in participants with a PAINS-pNF chronic target PN pain score of ≥ 3 at baseline is presented.","dispersionType":"Standard Error","groups":[{"description":"Actual Treatment Group","id":"OG000","title":"Selumetinib 25 mg/m2"},{"description":"Actual Treatment Group","id":"OG001","title":"Placebo"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"Pain full analysis set - subjects randomised to study intervention with a baseline PAINS-pNF chronic target PN pain intensity score \\>= 3.","reportingStatus":"POSTED","timeFrame":"Baseline and end of cycle 12 of study intervention","title":"(First Key Secondary) The Difference of the Means in the Change From Baseline in PAINS-pNF Chronic Target PN Pain Intensity Score at Cycle 12 Between Selumetinib and Placebo, Primary Analysis","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}