{"analyses":[{"ciLowerLimit":"0.41","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.69","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":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.53","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 = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.","groupId":"OG000","lowerLimit":"21.26","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"5.55","upperLimit":"15.38","value":"11.99"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"352"},{"groupId":"OG001","value":"334"}],"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. TTD was defined as the time to first onset of a ≥3-point decrease in symptom score from baseline with confirmation by the subsequent visit of a ≥3-point deterioration from baseline under right-censoring rule. 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 FKSI-DRS and have received at least one dose of the study intervention; and had data available for this TTD 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":"Up to approximately 39 months","title":"TTD in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score","type":"SECONDARY","unitOfMeasure":"Months"}