{"analyses":[{"ciLowerLimit":"0.70","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.19","estimateComment":"Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0002","paramType":"Difference in LS Means","paramValue":"1.45","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.70","upperLimit":"0.36","value":"-0.17"},{"groupId":"OG001","lowerLimit":"-2.17","upperLimit":"-1.06","value":"-1.62"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"363"},{"groupId":"OG001","value":"353"}],"units":"Participants"}],"description":"The FKSI-DRS was a questionnaire that asked the participant to rate 9 kidney cancer-related symptoms: lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or blood in the urine. Each item was scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (most severe symptoms) to 36 (no symptoms) with a higher score indicating a better outcome. The change from baseline to Week 17 in Disease Symptoms using the FKSI-DRS Items 1-9 score was calculated based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.","dispersionType":"95% Confidence Interval","groups":[{"description":"Randomized participants received 120 mg of belzutifan orally once daily (QD), until disease progression or discontinuation.","id":"OG000","title":"Belzutifan"},{"description":"Randomized participants received 10 mg of Everolimus orally QD, until disease progression or discontinuation.","id":"OG001","title":"Everolimus"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"Per protocol, the analysis population consisted of all randomized participants who have received at least one dose of the study intervention and had assessments available for FKSI-DRS at baseline or post-baseline up to Week 17; and had data available for this change from baseline in disease symptoms outcome using FKSI-DRS. Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures.","reportingStatus":"POSTED","timeFrame":"Baseline (Day 1) and week 17","title":"Change From Baseline to Week 17 in Disease Symptoms Using the FKSI-DRS Items 1-9 Score","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}