{"analyses":[{"groupDescription":"Year 1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.93","statisticalComment":"2-sided significance level = 0.05","statisticalMethod":"Chi-squared"},{"groupDescription":"Year 2","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.58","statisticalComment":"2-sided significance level = 0.05","statisticalMethod":"Chi-squared"},{"groupDescription":"Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \\[none\\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.9501","statisticalMethod":"Regression, Logistic"},{"groupDescription":"Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \\[none\\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1020","statisticalMethod":"Regression, Logistic"},{"groupDescription":"Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \\[none\\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1855","statisticalMethod":"Regression, Logistic"},{"groupDescription":"Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \\[N stage (NX)\\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5739","statisticalMethod":"Regression, Logistic"},{"groupDescription":"Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \\[N stage (NX)\\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0422","statisticalMethod":"Regression, Logistic"},{"groupDescription":"Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \\[N stage (NX)\\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5237","statisticalMethod":"Regression, Logistic"},{"groupDescription":"Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \\[N stage (NX)\\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4770","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"60.3","upperLimit":"84.1","value":"72.2"},{"groupId":"OG001","lowerLimit":"58.7","upperLimit":"84.1","value":"71.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"title":"Year 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"56.3","upperLimit":"80.5","value":"68.4"},{"groupId":"OG001","lowerLimit":"49.8","upperLimit":"76.8","value":"63.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"title":"Year 2"}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"108"}],"units":"Participants"}],"description":"The International Index of Erectile Function (IIEF) is a validated 15-item for measuring patient-reported erectile function. Question 1 asks \"How often were you able to get an erection during sexual activity?\" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at Years 1 and 2 are also reported with this outcome measure.","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"All randomized eligible patients with IIEF at both baseline and corresponding time point.","reportingStatus":"POSTED","timeFrame":"Baseline, 1 and 2 years from the start of tadalafil or placebo","title":"Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT","type":"SECONDARY","unitOfMeasure":"percentage of participants"}