{"analyses":[{"ciLowerLimit":"-1.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.59","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.918","paramType":"LS mean difference","paramValue":"-0.1","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":"0.45","value":"-0.4"},{"groupId":"OG001","spread":"0.44","value":"-0.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"59"}],"units":"Participants"}],"description":"PlexiQoL (Plexiform Neurofibroma Quality of Life scale) is a patient-derived QoL measure specific to adults with NF1-associated PNs. It assesses the impact of PNs on patients' ability to fulfil their human needs. The measure consists of 18 dichotomous items with 0 =Not True and 1 = True. PlexiQoL total scores were calculated by the sum of all items to a maximum of 18, with lower scores indicating better quality of life. The change from baseline to the end of each cycle in PlexiQoL total score was derived as the PlexiQoL total score at the cycle 12 minus baseline PlexiQoL total score and 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":"Full analysis set - subjects randomised to study intervention","reportingStatus":"POSTED","timeFrame":"Baseline and end of Cycle 12 of study intervention","title":"(Second Key Secondary Endpoint) The Difference of the Means in the Change From Baseline in PlexiQoL Total Score at Cycle 12","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}