{"analyses":[{"ciLowerLimit":"0.4546","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.9592","estimateComment":"Hazard ratio of palifermin over placebo based on Stratified Cox proportional hazard model.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0261","paramType":"Hazard Ratio (HR)","paramValue":"0.6603","statisticalComment":"Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).","statisticalMethod":"Stratified Log-Rank test","testedNonInferiority":false},{"ciPctValue":"95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1566","pValueComment":"Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.","statisticalMethod":"Stratified Log-Rank test","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"comment":"Could not be estimated due to the low number of events","groupId":"OG000","lowerLimit":"22.0","upperLimit":"NA","value":"35.0"},{"comment":"Could not be estimated due to the low number of events","groupId":"OG001","lowerLimit":"27.0","upperLimit":"NA","value":"47.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"94"}],"units":"Participants"}],"description":"Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure.\n\nParticipants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM.","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":"Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis","type":"SECONDARY","unitOfMeasure":"days"}