{"analyses":[{"ciLowerLimit":"0.070","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"4.748","dispersionType":"STANDARD_DEVIATION","dispersionValue":"6.82","groupDescription":"A type I error rate was protected by using the Hochberg procedure to adjust for multiple testing. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.095","pValueComment":"For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.","paramType":"Mean Difference (Final Values)","paramValue":"2.409","statisticalMethod":"van Elteren test","testedNonInferiority":false},{"ciLowerLimit":"-2.575","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"2.150","dispersionType":"STANDARD_DEVIATION","dispersionValue":"6.13","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.806","pValueComment":"For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.","paramType":"Mean Difference (Final Values)","paramValue":"-0.213","statisticalMethod":"van Elteren test","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","spread":"6.13","upperLimit":"32","value":"4.78"},{"groupId":"OG001","lowerLimit":"0","spread":"5.95","upperLimit":"25","value":"4.98"},{"groupId":"OG002","lowerLimit":"0","spread":"6.82","upperLimit":"27","value":"7.38"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"115"}],"units":"Participants"}],"description":"The duration of ulcerative mucositis measured the number of days the participants had different WHO grades 2, 3, and 4:\n\n2=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. Patients that did not have any ulcerative mucositis were given a value of 0 days.","dispersionType":"Full Range","groups":[{"description":"Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)","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 (total of 6 doses)","id":"OG002","title":"Palifermin Before and After"}],"paramType":"MEAN","populationDescription":"Full analysis set that includes all randomized subjects (total 281 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":"Duration of Ulcerative Mucositis (WHO Grades 2, 3, and 4)","type":"SECONDARY","unitOfMeasure":"Days"}