{"analyses":[{"groupDescription":"Week 30","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.70","statisticalComment":"Significance level = 0.05","statisticalMethod":"t-test, 2 sided"},{"groupDescription":"Year 1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.65","statisticalComment":"Significance level = 0.05","statisticalMethod":"t-test, 2 sided"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.72","statisticalComment":"Significance level = 0.05","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.3","value":"-2.0"},{"groupId":"OG001","spread":"8.0","value":"-2.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"title":"Week 30"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.7","value":"-3.7"},{"groupId":"OG001","spread":"9.9","value":"-4.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"24"}],"units":"Participants"}],"title":"Year 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.3","value":"-3.4"},{"groupId":"OG001","spread":"14.8","value":"-4.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Year 2"}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"51"}],"units":"Participants"}],"description":"The Sexual Adjustment Questionnaire (SAQ) is a 20-item questionnaire with an overall score range between 8 and 100 including the following domains: desire, ranging between 5 and 30; dysfunction, 0 and 25; activity, 0 and 10; satisfaction, 1 and 10; and fatigue, 1 and 5. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.","dispersionType":"Standard Deviation","groups":[{"description":"Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.","id":"OG000","title":"Tadalafil"},{"description":"Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.","id":"OG001","title":"Placebo"}],"paramType":"MEAN","populationDescription":"Eligible patients with data at baseline and corresponding time point","reportingStatus":"POSTED","timeFrame":"Baseline, week 30 and years 1 and 2 after the start of treatment","title":"Overall Patient Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire (SAQ) Score","type":"SECONDARY","unitOfMeasure":"change in SAQ score"}