{"analyses":[{"groupDescription":"End of RT","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalComment":"Two-sided significance level = 0.05","statisticalMethod":"Fisher Exact"},{"groupDescription":"One month after end of RT","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.17","statisticalComment":"Two-sided significance level = 0.05","statisticalMethod":"Fisher Exact"},{"groupDescription":"Six months after end of RT","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.16","statisticalComment":"Two-side significance level = 0.05","statisticalMethod":"Fisher Exact"},{"groupDescription":"One year after end of RT","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.26","statisticalComment":"Two-side significance level = 0.05","statisticalMethod":"Fisher Exact"},{"groupDescription":"Two years after the end of RT","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.82","statisticalComment":"Two-side significance level = 0.05","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"65.9","upperLimit":"80.5","value":"73.7"},{"groupId":"OG001","lowerLimit":"38.0","upperLimit":"54.7","value":"46.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"147"}],"units":"Participants"}],"title":"End of RT"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"28.3","upperLimit":"44.5","value":"36.1"},{"groupId":"OG001","lowerLimit":"21.0","upperLimit":"36.3","value":"28.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"142"}],"units":"Participants"}],"title":"1 month post-RT"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.9","upperLimit":"25.2","value":"17.9"},{"groupId":"OG001","lowerLimit":"6.2","upperLimit":"17.9","value":"11.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"126"}],"units":"Participants"}],"title":"6 months post-RT"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.8","upperLimit":"20.8","value":"14.0"},{"groupId":"OG001","lowerLimit":"4.7","upperLimit":"15.1","value":"9.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"143"},{"groupId":"OG001","value":"134"}],"units":"Participants"}],"title":"1 year post-RT"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.4","upperLimit":"14.9","value":"8.6"},{"groupId":"OG001","lowerLimit":"3.4","upperLimit":"13.5","value":"7.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"122"}],"units":"Participants"}],"title":"2 years post-RT"}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"147"}],"units":"Participants"}],"description":"Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 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 AE.","dispersionType":"95% Confidence Interval","groups":[{"description":"Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks\n\nIMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy","id":"OG000","title":"IMRT 6 Weeks + Cisplatin (Arm 1)"},{"description":"IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy","id":"OG001","title":"IMRT 5 Weeks (Arm 2)"}],"paramType":"NUMBER","populationDescription":"Randomized and eligible participants who started study treatment. Adverse event data was not available for all participants at each time point.","reportingStatus":"POSTED","timeFrame":"End of radiation therapy (RT) (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2), then 1 month, 6 months, 1 year, and two years after end of RT","title":"Percentage of Participants With Grade 3+ Adverse Events","type":"SECONDARY","unitOfMeasure":"percentage of participants"}