{"analyses":[{"ciPctValue":"95","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.78","pValueComment":"0.78 (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":"12.61","value":"84.52"},{"groupId":"OG001","spread":"10.92","value":"82.93"},{"groupId":"OG002","spread":"12.49","value":"83.49"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"26"}],"units":"Participants"}],"description":"Functional status of participants was measured by administering the KPS which contains items asking about performing daily activities. The scores are grouped in 10s ranging from 100 (Normal, no complaints) to 0 (Dead), with higher scores indicating better functional status. The KPS was administered at baseline, during radiotherapy, and once a month for 3 months after radiation therapy. Scores at all time points were combined to compute one mean to determine overall performance status 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 Karnofsky functional scales 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 Karnofsky Performance Status Scale (KPS) by Group","type":"SECONDARY","unitOfMeasure":"score on a scale"}