{"analyses":[{"ciPctValue":"95","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.22","pValueComment":"0.22 (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":"2.40","value":"2.15"},{"groupId":"OG001","spread":"2.26","value":"1.72"},{"groupId":"OG002","spread":"2.65","value":"2.15"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"27"}],"units":"Participants"}],"description":"Severity and quality of pain was measured using a pain questionnaire developed for this study with total scores ranging from 0 (no pain) to 10 (most intense pain) with higher scores indicating a greater level of pain. The questionnaire was administered at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Scores at all time points were combined to compute one mean to determine overall pain intensity score during the course of 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 pain questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.","reportingStatus":"POSTED","timeFrame":"Up to 3 months","title":"Comparison of Combined Mean Score on the Pain Questionnaire by Group","type":"SECONDARY","unitOfMeasure":"score on a scale"}