{"analyses":[{"groupDescription":"With an expected percentage of erectile disfunction (ED) at 12 months of 29%, a two-sided significance level of 0.05, and 688 patients per arm provides 90% statistical power to detect a reduction in ED to 19%. This calculation assumes 26% ED at baseline and 80% compliance at 12 months. Only participants with baseline ED are analyzed.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0513","statisticalComment":"Two-sided significance level = 0.05","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"29.84","upperLimit":"46.28","value":"38.06"},{"groupId":"OG001","lowerLimit":"41.52","upperLimit":"57.79","value":"49.66"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"description":"The International Index of Erectile Function Questionnaire (IIEF) is the primary measure for erectile function (ED). IIEF question number 1 (\"How often were you able to get an erection during sexual activity?\") is scored from: none/almost never (response 0-1) or \\< half the time (response 2-3) to most times/almost always/always (response 4-5). A response of 0 to 3 on question number 1 of the IIEF is considered erectile dysfunction.","dispersionType":"95% Confidence Interval","groups":[{"description":"70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.","id":"OG000","title":"70.2 Gy"},{"description":"79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.","id":"OG001","title":"79.2 Gy"}],"paramType":"NUMBER","populationDescription":"Eligible patients with a response of 4 or 5 (most times/almost always/always) to IIEF question 1 at baseline","reportingStatus":"POSTED","timeFrame":"Twelve months from randomization","title":"Percentage of Participants With Erectile Disfuction at 12 Months","type":"SECONDARY","unitOfMeasure":"percentage of participants"}