{"analyses":[{"groupDescription":"A mixed effects model was run with MDASI Symptom Severity Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Each explanatory variable is reported separately. (Time and intercept effects are not shown.)","nonInferiorityType":"SUPERIORITY","pValue":"0.1702","statisticalMethod":"Mixed Models Analysis"},{"groupDescription":"A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.8159","statisticalComment":"Each explanatory variable is reported separately. (Time and intercept effects are not shown.)","statisticalMethod":"Mixed Models Analysis"},{"groupDescription":"A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT status is reported here.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2174","statisticalComment":"Each explanatory variable is reported separately. (Time and intercept effects are not shown.)","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.0","upperLimit":"1.5","value":"1.3"},{"groupId":"OG001","lowerLimit":"0.8","upperLimit":"1.4","value":"1.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"86"}],"units":"Participants"}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.1","upperLimit":"1.7","value":"1.4"},{"groupId":"OG001","lowerLimit":"1.1","upperLimit":"1.6","value":"1.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"74"}],"units":"Participants"}],"title":"Week 10 (Cycle 1)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.2","upperLimit":"2.1","value":"1.6"},{"groupId":"OG001","lowerLimit":"1.1","upperLimit":"1.8","value":"1.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"37"}],"units":"Participants"}],"title":"Week 12 (Cycle 1.5)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.7","upperLimit":"1.3","value":"1.0"},{"groupId":"OG001","lowerLimit":"0.9","upperLimit":"1.5","value":"1.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"40"}],"units":"Participants"}],"title":"Week 22 (Cycle 4)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.7","upperLimit":"1.3","value":"1.0"},{"groupId":"OG001","lowerLimit":"0.7","upperLimit":"1.6","value":"1.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"24"}],"units":"Participants"}],"title":"Week 24 (Cycle 4.5)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.7","upperLimit":"1.6","value":"1.2"},{"groupId":"OG001","lowerLimit":"0.7","upperLimit":"1.6","value":"1.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Week 46 (Cycle 10)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"96"}],"units":"Participants"}],"description":"The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed.","dispersionType":"95% Confidence Interval","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 for 6 cycles, up to 12 cycles.","id":"OG001","title":"Dose-dense Adjuvant TMZ"}],"paramType":"MEAN","populationDescription":"Questionnaires were not completed by all QOL population participants. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.","reportingStatus":"POSTED","timeFrame":"Baseline, 10, 12, 22, 24, and 46 weeks","title":"Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time","type":"SECONDARY","unitOfMeasure":"score on a scale"}