{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.59","statisticalComment":"Two-sided significance level = 0.05","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"91"}],"title":"Improved"},{"measurements":[{"groupId":"OG000","value":"366"},{"groupId":"OG001","value":"331"}],"title":"Stable"},{"measurements":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"95"}],"title":"Declined"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"547"},{"groupId":"OG001","value":"517"}],"units":"Participants"}],"description":"The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows:\n\nImprovement: when change \\>= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM \\< change \\< SEM; Declined: when change \\<= SEM.","groups":[{"description":"70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.","id":"OG000","title":"70.2 Gy"},{"description":"79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.","id":"OG001","title":"79.2 Gy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Eligible participants with baseline and 12 month SQLI","reportingStatus":"POSTED","timeFrame":"Baseline and 12 months from randomization","title":"Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months","type":"SECONDARY","unitOfMeasure":"Participants"}