{"classes":[{"categories":[{"measurements":[{"comment":"TTD median not reached by the time of the data cutoff (24-Aug-2018). For TTD upper limit, no deterioration reached by the time of last disease assessment.","groupId":"OG000","lowerLimit":"12.7","upperLimit":"NA","value":"NA"},{"comment":"TTD median not reached by the time of the data cutoff (24-Aug-2018). For TTD lower and upper limit, no deterioration reached by the time of last disease assessment.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"395"},{"groupId":"OG001","value":"387"}],"units":"Participants"}],"description":"TTD was defined as time (in months) from the first dose of study treatment to the date of deterioration of FKSI-DRS Score. 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. Deterioration was defined as a 3-point decrease (i.e. lower score) in symptom score and the time to true deterioration was the time to first onset of 3 or more decreases from baseline with confirmation under right-censoring rule (the last observation). The time to true deterioration as measured in months is presented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.","id":"OG000","title":"Pembrolizumab + Axitinib"},{"description":"Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.","id":"OG001","title":"Sunitinib"}],"paramType":"MEDIAN","populationDescription":"All randomized participants who received at least 1 dose of study medication and completed at least 1 questionnaire assessment.","reportingStatus":"POSTED","timeFrame":"Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)","title":"Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score","type":"SECONDARY","unitOfMeasure":"Months"}