{"analyses":[{"ciPctValue":"95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0160","pValueComment":"Generalized Cochran-Mantel-Haenszel test for mean score difference.","paramType":"Chi-Square Statistic","paramValue":"5.8002","statisticalComment":"Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"ciPctValue":"95","groupDescription":"To protect the overall type 1 error, the Hochberg procedure was used to adjust for multiple statistical testing of the secondary efficacy endpoints.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1122","pValueComment":"Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"50.0","value":"26.0"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"40.0","value":"5.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"94"}],"units":"Participants"}],"description":"The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.","dispersionType":"Inter-Quartile Range","groups":[{"description":"Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.","id":"OG000","title":"Placebo"},{"description":"Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.","id":"OG001","title":"Palifermin"}],"paramType":"MEDIAN","populationDescription":"Full analysis set","reportingStatus":"POSTED","timeFrame":"Up to 15 weeks","title":"Duration of Severe (WHO Grade 3 or 4) Oral Mucositis","type":"SECONDARY","unitOfMeasure":"days"}