{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"24","value":"32"},{"groupId":"OG001","spread":"23","value":"13"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days \\[15 weeks\\] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0.\n\nThis study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05.\n\nStatistical testing was not done due to the small sample size.","dispersionType":"Standard Deviation","groups":[{"description":"Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.","id":"OG000","title":"Placebo"},{"description":"Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.","id":"OG001","title":"Palifermin"}],"paramType":"MEAN","populationDescription":"All eligible patients.","reportingStatus":"POSTED","timeFrame":"Twice-weekly from start of treatment up to 15 weeks after the start of treatment.","title":"Duration of Oral Mucositis as Measured in Terms of Days","type":"PRIMARY","unitOfMeasure":"Days"}