{"analyses":[{"ciPctValue":"95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0463","pValueComment":"Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed to have the event.","paramType":"Chi-Square Statistic","paramValue":"3.9715","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","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2314","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","value":"57"},{"groupId":"OG001","value":"37"}]}],"title":"Yes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"31"}]}],"title":"No"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"26"}]}],"title":"Unknown"}],"denoms":[{"counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"94"}],"units":"Participants"}],"description":"The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale.","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":"NUMBER","populationDescription":"Full Analysis Set","reportingStatus":"POSTED","timeFrame":"Month 4","title":"Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)","type":"SECONDARY","unitOfMeasure":"participants"}