{"analyses":[{"groupDescription":"Acute radiotherapy toxicity","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.060","statisticalMethod":"Chi-squared"},{"groupDescription":"Hormone therapy and late radiotherapy toxicity","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.029","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"8"}]}],"title":"Acute radiotherapy toxicity"},{"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"100"}]}],"title":"Hormone therapy and late radiotherapy toxicity"}],"denoms":[{"counts":[{"groupId":"OG000","value":"374"},{"groupId":"OG001","value":"382"}],"units":"Participants"}],"description":"Adverse events are graded using the Cooperative Group Common Toxicity Criteria and the Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring. Grade refers to severity, assigning Grades 1 through 5 based on this general guideline: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity. Toxicities reported to have occurred within 90 days from the start of radiotherapy are reported as \"Acute Radiotherapy\", all later toxicities are reported as \"Hormone therapy and late radiotherapy toxicity\". The highest grade toxicity event per subject is counted within each of these time periods. Four-year follow-up was required of all patients; patients are followed until death.","groups":[{"description":"Radiation therapy (64.8 Gy) + placebo (daily 2 years)","id":"OG000","title":"Placebo"},{"description":"Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)","id":"OG001","title":"Bicalutamide"}],"paramType":"NUMBER","populationDescription":"Eligible patients who started protocol treatment and did not withdraw consent.","reportingStatus":"POSTED","timeFrame":"From date of randomization to four years.","title":"Grade 3+ Toxicity","type":"SECONDARY","unitOfMeasure":"participants"}