{"analyses":[{"ciLowerLimit":"-0.59","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.54","estimateComment":"Based on a cLDA model with 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":"0.1134","paramType":"Difference in LS Means","paramValue":"2.47","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-6.87","upperLimit":"-2.63","value":"-4.75"},{"groupId":"OG001","lowerLimit":"-9.47","upperLimit":"-4.98","value":"-7.22"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"363"},{"groupId":"OG001","value":"353"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. The change from baseline to Week 17 in physical functioning (EORTC QLQ-C30 Items 1-5) score was calculated based on a constrained longitudinal data analysis (cLDA) model with 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 EORTC QLQ-C30 at baseline or post-baseline up to Week 17; and had data available for this change from baseline in physical functioning outcome using EORTC QLQ-C30. 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 Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}