{"analyses":[{"ciPctValue":"95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0712","pValueComment":"Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score","paramType":"Chi-Square Statistic","paramValue":"3.2548","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":"0.2849","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","spread":"0.65","value":"1.86"},{"groupId":"OG001","spread":"0.73","value":"1.66"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"description":"The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer \\[OMWQ-HN\\]): \"How much mouth and throat soreness did you experience in the past 24 hours?\" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness).\n\nFor each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"The Patient Reported Outcome-evaluable analysis set included all randomized patients with a valid Baseline assessment for MTS question 3 of the OMWQ-HN and either:\n\n* At least 1 completed assessment each week for MTS up to withdrawal/Week 8, whichever came first, or\n* 70% or greater overall compliance for MTS until withdrawal/Week 8.","reportingStatus":"POSTED","timeFrame":"Assessed twice a week for up to 15 weeks.","title":"Patient-Reported Mouth and Throat Soreness Score","type":"SECONDARY","unitOfMeasure":"units on a scale"}