{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.016","statisticalComment":"2-sided significance level of 0.05","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.9","value":"-0.41"},{"groupId":"OG001","spread":"22.5","value":"-5.11"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"226"}],"units":"Participants"}],"description":"The Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) is a 10-item self-report instrument designed to measure multidimensional quality of life in patients with head and neck cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-40. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-HN including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Change from baseline to 12 months (12 months - baseline) is reported.","dispersionType":"Standard Deviation","groups":[{"description":"Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin","id":"OG000","title":"RT + Cisplatin"},{"description":"Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab","id":"OG001","title":"RT + Cisplatin + Cetuximab"}],"paramType":"MEAN","populationDescription":"Randomized eligible patients with baseline and 12-month FACT-HN data.","reportingStatus":"POSTED","timeFrame":"Baseline and 12 months","title":"Quality of Life as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-HN) at 12 Months","type":"SECONDARY","unitOfMeasure":"units on a scale"}