{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalComment":"Two-sided significance level of 0.05","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"175"}],"title":"Grade 0,1,2"},{"measurements":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"194"}],"title":"Grade 3,4,5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"351"},{"groupId":"OG001","value":"369"}],"units":"Participants"}],"description":"Highest grade adverse event (AE) per subject was counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the 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 AE. Analysis occurred after 647 deaths were reported.","groups":[{"description":"Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.","id":"OG000","title":"Conventional Adjuvant TMZ"},{"description":"Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.","id":"OG001","title":"Dose-dense Adjuvant TMZ"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Randomized eligible patients with any adverse events reported as possibly/probably/definitely related to protocol treatment","reportingStatus":"POSTED","timeFrame":"From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.","title":"Distribution of Highest Grade AE Reported as Possibly/Probably/Definitely Related to Protocol Treatment","type":"SECONDARY","unitOfMeasure":"Participants"}