{"analyses":[{"ciPctValue":"95","groupDescription":"Fisher's exact two tailed test","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.09","statisticalComment":"Two by two table was used. One cell had expected frequency test less than five, so Fisher's exact two-tailed test was used.","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"46"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"53"}],"units":"Participants"}],"description":"The number of participants with recorded grade 1 (mild; Irritation, may experience slight pain, not requiring analgesic) or grade 2 (moderate; Patchy mucositis that may produce inflammatory serosanguinitis discharge; may experience moderate pain requiring analgesia) oral mucositis using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy will be recorded. The RTOG grading is reliant on a clinician's ability to judge the anatomical changes associated with oral mucositis (size and characteristics of ulceration), with symptoms ranging from Grade 0 (no symptoms) to Grade 4 (Ulceration, hemorrhage, or necrosis). A comparison of incidence in the GM-CSF Group (GG) and Arm II: Salt \\& Soda Group (SS) will be reported.","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)"}],"paramType":"NUMBER","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 baseline to onset of mucositis, approximately 16 days","title":"Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)","type":"PRIMARY","unitOfMeasure":"participants"}