{"analyses":[{"groupDescription":"Diet 3-month","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.13","statisticalComment":"2-sided significance level of 0.05","statisticalMethod":"Chi-squared"},{"groupDescription":"Diet 12-month","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.87","statisticalComment":"2-sided significance level 0.05","statisticalMethod":"Chi-squared"},{"groupDescription":"Eating 3-month","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.39","statisticalComment":"2-sided significance level of 0.05","statisticalMethod":"Chi-squared"},{"groupDescription":"Eating 12-month","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.16","statisticalComment":"2-sided significance level of 0.05","statisticalMethod":"Chi-squared"},{"groupDescription":"Speech 3-month","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.81","statisticalComment":"2-sided significance level of 0.05","statisticalMethod":"Chi-squared"},{"groupDescription":"Speech 12-month","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.67","statisticalComment":"2-sided significance level of 0.05","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.75","upperLimit":"0.84","value":"0.80"},{"groupId":"OG001","lowerLimit":"0.80","upperLimit":"0.89","value":"0.85"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"282"},{"groupId":"OG001","value":"272"}],"units":"Participants"}],"title":"Normalcy of Diet 3 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.31","upperLimit":"0.43","value":"0.37"},{"groupId":"OG001","lowerLimit":"0.31","upperLimit":"0.44","value":"0.37"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"234"},{"groupId":"OG001","value":"223"}],"units":"Participants"}],"title":"Normalcy of Diet 12 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.56","upperLimit":"0.67","value":"0.62"},{"groupId":"OG001","lowerLimit":"0.59","upperLimit":"0.67","value":"0.63"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"283"},{"groupId":"OG001","value":"272"}],"units":"Participants"}],"title":"Public Eating 3 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.13","upperLimit":"0.23","value":"0.18"},{"groupId":"OG001","lowerLimit":"0.18","upperLimit":"0.28","value":"0.23"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"234"},{"groupId":"OG001","value":"230"}],"units":"Participants"}],"title":"Public Eating 12 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.06","upperLimit":"0.12","value":"0.09"},{"groupId":"OG001","lowerLimit":"0.05","upperLimit":"0.12","value":"0.08"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"277"}],"units":"Participants"}],"title":"Understandability of Speech 3 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.02","upperLimit":"0.08","value":"0.05"},{"groupId":"OG001","lowerLimit":"0.02","upperLimit":"0.07","value":"0.04"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"238"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"title":"Understandability of Speech 12 months"}],"denoms":[{"counts":[{"groupId":"OG000","value":"447"},{"groupId":"OG001","value":"444"}],"units":"Participants"}],"description":"The PSS-HN is a clinician rated instrument consisting of assessment of three functions (subscales): Normalcy of Diet, Eating in Public, and Understandability of Speech. The interviewer rates the patient on each scale based on the patient's responses to targeted questions. Scores on each subscale range from 0-100, with higher scores indicating better performance. It has been demonstrated to be reliable and valid in head and neck cancer patients.The site research nurse or clinical research associate (CRA) will determine the score on each of the subscales by performing a clinical evaluation and unstructured interview format. The PSS-HN takes approximately 5 minutes to complete.","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"Randomized eligible patients with PSS-HN data at the given time point.","reportingStatus":"POSTED","timeFrame":"3 months and 12 months","title":"Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50","type":"SECONDARY","unitOfMeasure":"proportion of participants"}