{"analyses":[{"groupDescription":"A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 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"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2184","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, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. RPA class is reported here.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0763","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, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. MGMT status is reported here.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5235","statisticalComment":"Each explanatory variable is reported separately. (Time and intercept effects are not shown.)","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-6.1","upperLimit":"6.1","value":"0.0"},{"groupId":"OG001","lowerLimit":"-8.7","upperLimit":"2.9","value":"-2.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"72"}],"units":"Participants"}],"title":"Week 10 (Cycle 1)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-12.6","upperLimit":"3.5","value":"-4.6"},{"groupId":"OG001","lowerLimit":"-11.3","upperLimit":"6.1","value":"-2.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"38"}],"units":"Participants"}],"title":"Week 12 (Cycle 1.5)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.5","upperLimit":"10.4","value":"3.9"},{"groupId":"OG001","lowerLimit":"-12.1","upperLimit":"3.3","value":"-4.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"38"}],"units":"Participants"}],"title":"Week 22 (Cycle 4)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-13.9","upperLimit":"8.3","value":"-2.8"},{"groupId":"OG001","lowerLimit":"-11.9","upperLimit":"10.5","value":"-0.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"title":"Week 24 (Cycle 4.5)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.5","upperLimit":"18.3","value":"5.4"},{"groupId":"OG001","lowerLimit":"-9.8","upperLimit":"6.0","value":"-1.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Week 46 (Cycle 10)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"95"}],"units":"Participants"}],"description":"Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \\[EORTC QLQ\\]-C30. The question responses range from 1 \"very poor\" to 7 \"excellent\" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline was calculated as time point value - baseline value with a positive change value indicating improved QOL from baseline.","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 for 6 cycles, up to 12 cycles.","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":"Change From Baseline in Mean EORTC QLQ-C30 Global Health Status","type":"SECONDARY","unitOfMeasure":"score on a scale"}