{"analyses":[{"ciNumSides":"TWO_SIDED","ciPctValue":"95","groupDescription":"Kaplan-Meier estimate of the survival curves used information from subjects who develop mucositis to the healing of the mucositis in three groups, Group GG, SS, and SG. In order to compare the three curves that were created, the Mantel-Haenszel log-rank statistic was used","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.92","statisticalComment":"Log rank, Breslow, Tarone-Ware test, but used mantel cox log rank for this analysis","statisticalMethod":"Mantel Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"63.43","value":"81.5"},{"groupId":"OG001","spread":"31.24","value":"79.4"},{"groupId":"OG002","spread":"37.40","value":"77.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"19"}],"units":"Participants"}],"description":"The mean number of days for mucositis to heal will be used to evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring.","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":"Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash","reportingStatus":"POSTED","timeFrame":"From onset of mucositis to healing of mucositis, approximately 80 days","title":"Comparison of the Mean Number of Days for Mucositis to Heal Across by Group","type":"PRIMARY","unitOfMeasure":"days"}