{"analyses":[{"ciLowerLimit":"1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"9","groupDescription":"Sample size calculations were based on the hypothesis that the use of tadalafil would statistically significant increase the proportion of patients maintaining spontaneous erectile function compared to the use of placebo. Based on a 2-sided Fisher exact test with alpha=0.05, 91 patients/arm would provide 80% statistical power to detect an increase from 20% to 40% in spontaneous erectile response at weeks 28-30. Although designed for the Fisher exact test, Chi-square was used and reported.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.49","paramType":"Difference in percentages","paramValue":"5","statisticalMethod":"Chi-squared"},{"groupDescription":"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 vs. N0)\\] were retained in the model. (Dropped: ethnicity, Zubrod, T stage, prostate-specific antigen (PSA).) The results for each explanatory variable are reported separately. Treatment arm is reported here.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2386","statisticalMethod":"Regression, Logistic"},{"groupDescription":"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 vs. N0)\\] 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":"0.7908","statisticalMethod":"Regression, Linear"},{"groupDescription":"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 vs. N0)\\] 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":"0.0467","statisticalMethod":"Regression, Logistic"},{"groupDescription":"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 vs. N0)\\] 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":"0.0068","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"70","upperLimit":"88","value":"79"},{"groupId":"OG001","lowerLimit":"63","upperLimit":"85","value":"74"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"61"}],"units":"Participants"}],"description":"EF is measured by Question 1 of the International Index of Erectile Function (IIEF). The 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 on IIEF Q1. 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 this time point 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 30 week time point.","reportingStatus":"POSTED","timeFrame":"Baseline and 30 weeks from the start of radiation therapy","title":"Percentage of Patients Maintaining Spontaneous (Off-drug) Erectile Function (EF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}