{"analyses":[{"groupDescription":"A sample size of 42 patients provides 64% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 25%.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.12","statisticalMethod":"Chi-squared"},{"groupDescription":"A sample size of 42 patients provides 88% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 20%.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.043","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.6","upperLimit":"42.8","value":"27.9"},{"groupId":"OG001","lowerLimit":"12.1","upperLimit":"37.7","value":"22.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"40"}],"units":"Participants"}],"description":"Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.","dispersionType":"95% Confidence Interval","groups":[{"description":"Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)","id":"OG000","title":"Endometrial Cancer: IMRT"},{"description":"Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)","id":"OG001","title":"Cervical Cancer: IMRT + Chemotherapy (Cisplatin)"}],"paramType":"NUMBER","populationDescription":"Eligible patients who started study treatment","reportingStatus":"POSTED","timeFrame":"From the start of treatment to 90 days.","title":"Percentage of Patients With Grade 2+ Bowel Adverse Events","type":"SECONDARY","unitOfMeasure":"percentage of participants"}