{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0002","statisticalComment":"Two-sided test","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}],"title":"Symptom Severity and GHS deterioration"},{"measurements":[{"groupId":"OG000","value":"9"}],"title":"Symptom Severity deterioration only"},{"measurements":[{"groupId":"OG000","value":"31"}],"title":"GHS deterioratoin only"},{"measurements":[{"groupId":"OG000","value":"78"}],"title":"No deterioration"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"136"}],"units":"Participants"}],"description":"* The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) 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). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration.\n* 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). A score worse than baseline by at least 10 is considered deterioration.\n* The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.","groups":[{"description":"Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, either \\[100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle\\] or \\[75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle\\] for 6 cycles, up to 12 cycles.","id":"OG000","title":"Both Arms Combined"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Per the protocol, both arms are combined. Questionnaires were not completed by all QOL population participants. Therefore, only 136/191 have both MDASI-BT and EORTC QLQ-C30 at baseline and cycle 1.","reportingStatus":"POSTED","timeFrame":"baseline and cycle 1 (approximately 10 weeks)","title":"Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 1","type":"SECONDARY","unitOfMeasure":"Participants"}