{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.02","statisticalComment":"Two-sided test","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}],"title":"Cognitive and HVLT-R deterioration"},{"measurements":[{"groupId":"OG000","value":"12"}],"title":"Cognitive deterioration only"},{"measurements":[{"groupId":"OG000","value":"20"}],"title":"HVLT-R deterioration only"},{"measurements":[{"groupId":"OG000","value":"74"}],"title":"No deterioration"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"116"}],"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* The HVLT-R Delayed Recognition raw score is the number of of correctly identified words minus the number of incorrectly identified words from a list of words including 12 nouns memorized 20 minutes prior. The raw score ranges from -12 to 12. with a higher score indicates better functioning. Scores are standardized (mean 0, standard deviation 1), adjusting for age,education, and gender as necessary. A score worse than baseline by at least two is considered deterioration.\n* The 2x2 frequency table of SS deterioration vs. HVLT-R 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":"Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 116/191 have both MDASI-BT and HVLT-R 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) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition Score at Cycle 1","type":"SECONDARY","unitOfMeasure":"Participants"}