{"analyses":[{"groupDescription":"Week 30","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.97","statisticalComment":"Significance level = 0.05","statisticalMethod":"t-test, 2 sided"},{"groupDescription":"Year 1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.99","statisticalComment":"Significance level = 0.05","statisticalMethod":"t-test, 2 sided"},{"groupDescription":"Year 2","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.24","statisticalComment":"Significance level = 0.05","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.4","value":"-8.2"},{"groupId":"OG001","spread":"17.0","value":"-9.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"58"}],"units":"Participants"}],"title":"Week 30"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.8","value":"-9.5"},{"groupId":"OG001","spread":"18.4","value":"-10.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"45"}],"units":"Participants"}],"title":"Year 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.7","value":"-9.7"},{"groupId":"OG001","spread":"20.1","value":"-14.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"45"}],"units":"Participants"}],"title":"Year 2"}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"108"}],"units":"Participants"}],"description":"The IIEF is a validated 15-item for measuring patient-reported erectile function. A score of 0-5 is given to each of the 15 questions that examine 5 main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Domain scores are the sum of each item. The erectile function domain has 5 items with a score range of 1-30, orgasmic function has 2 items with a score range of 0-10, sexual desire has 2 items with a score range of 0-10, intercourse satisfaction has 3 items with a score range of 0-15, and overall satisfaction has 2 items with a score range of 2-10. Total score ranges from 0-70, with higher scores indicated better functioning. Change from baseline is calculated by subtracting baseline score from score at the time point of interest.","dispersionType":"Standard Deviation","groups":[{"description":"Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg 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 IIEF at baseline and corresponding time points.","reportingStatus":"POSTED","timeFrame":"Baseline, week 30, and years 1 and 2 from start of treatment","title":"Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF)","type":"SECONDARY","unitOfMeasure":"change in total IIEF"}