{"analyses":[{"ciLowerLimit":"0.351","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.313","estimateComment":"The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.","groupDescription":"The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.188","pValueComment":"A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.","paramType":"Odds Ratio (OR)","paramValue":"0.679","statisticalComment":"The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.","statisticalMethod":"Proportional odds model","testedNonInferiority":false},{"ciLowerLimit":"0.635","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"2.431","estimateComment":"The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.","groupDescription":"The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.468","pValueComment":"A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.","paramType":"Odds Ratio (OR)","paramValue":"1.242","statisticalComment":"The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.","statisticalMethod":"Proportional odds model","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"68"}]}],"title":"WHO grade 0/1 or 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"44"}]}],"title":"WHO grade 3 or 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"}]}],"title":"Unknown"}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"115"}],"units":"Participants"}],"description":"For the primary efficacy endpoint maximum severity of Oral Mucositis (OM) was assessed, the number of participants who had the different severity. To assess severity of OM, a 5-grade WHO scale (0, 1, 2, 3, or 4) was used.\n\n0 = no findings or erythema only, 1= soreness present with or without erythema, 2=ulcers present but able to take solid food, 3 =ulcers present and only able to take liquids, 4 =ulcers present/not able to take anything orally.","groups":[{"description":"Subjects to receive palifermin before-high dose chemotherapy and matched placebo after-high dose chemotherapy","id":"OG000","title":"Palifermin Before Only"},{"description":"Subjects to receive matched placebo before- and after-high dose chemotherapy","id":"OG001","title":"Placebo"},{"description":"Subjects to receive palifermin before- and after-high dose chemotherapy","id":"OG002","title":"Palifermin Before and After"}],"paramType":"NUMBER","populationDescription":"Full analysis set that includes all randomized subjects, and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.","reportingStatus":"POSTED","timeFrame":"at Day 32","title":"Maximum Severity of Oral Mucositis (World Health Organization (WHO) Grades 0/1, 2, 3, or 4)","type":"PRIMARY","unitOfMeasure":"Participants"}