{"analyses":[{"ciPctValue":"95","groupDescription":"Multilevel regression was used.","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.28","pValueComment":"0.28 (quadratic)","statisticalComment":"Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.59","value":"6.91"},{"groupId":"OG001","spread":"1.46","value":"6.80"},{"groupId":"OG002","spread":"1.53","value":"6.77"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"27"}],"units":"Participants"}],"description":"Quality of life at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. The items on the quality of life questionnaire developed for the study range in scores from 0-10 with higher scores indicating a better quality of life. Scores at all time points were combined to compute one mean score for overall quality of life during the study.","dispersionType":"Standard Deviation","groups":[{"description":"Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.","id":"OG000","title":"Arm I: GM-CSF Group (GG)"},{"description":"Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.","id":"OG001","title":"Arm II: Salt & Soda Group (SS)"},{"description":"Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.","id":"OG002","title":"Arm III: Salt & Soda Switched to GM-CSF (SG)"}],"paramType":"MEAN","populationDescription":"Of the intent to treat population, subjects who did not fill out the baseline quality of life questionnaires were not included in our analysis.","reportingStatus":"POSTED","timeFrame":"Up to 3 months","title":"Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by Group","type":"SECONDARY","unitOfMeasure":"score on a scale"}