{"analyses":[{"ciPctValue":"95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.9587","pValueComment":"Generalized Cochran-Mantel-Haenszel test for general association.","paramType":"Chi-Square Statistic","paramValue":"0.0027","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":"0.9587","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":"11"},{"groupId":"OG001","value":"13"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"94"}],"units":"Participants"}],"description":"Participants with a duration of 5 days or more without an administration of radiotherapy or who discontinue radiotherapy prior to completion of planned radiotherapy were considered to have an unplanned break in radiotherapy.","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":"During the 7 weeks of radiotherapy","title":"Number of Participants With Unplanned Breaks in Radiotherapy","type":"SECONDARY","unitOfMeasure":"participants"}