{"analyses":[{"ciLowerLimit":"0.72","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.20","estimateComment":"Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.5533","paramType":"Hazard Ratio (HR)","paramValue":"0.93","statisticalComment":"Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.","groupId":"OG000","lowerLimit":"11.11","upperLimit":"NA","value":"19.32"},{"comment":"NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.","groupId":"OG001","lowerLimit":"10.61","upperLimit":"NA","value":"13.83"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"351"},{"groupId":"OG001","value":"333"}],"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. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. If the first deterioration is at the last PRO assessment timepoint at the time of analysis, then no confirmation is required. A longer TTD indicates a better outcome. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.","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":"MEDIAN","populationDescription":"Per protocol, the analysis population consisted of all randomized participants who have at least one assessment available for EORTC QLQ-C30 and have received at least one dose of the study intervention; and had data available for this TTD 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":"Up to approximately 39 months","title":"TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score","type":"SECONDARY","unitOfMeasure":"Months"}