{"analyses":[{"ciLowerLimit":"-4.303","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"30.828","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.245","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":"Risk Difference (RD)","paramValue":"13.262","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"ciLowerLimit":"-20.519","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"16.491","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":"Risk Difference (RD)","paramValue":"-2.014","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"79"}]}],"title":"Incidence (n): yes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"33"}]}],"title":"Incidence (n): No"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"}]}],"title":"Incidence (n): unknown"}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"115"}],"units":"Participants"}],"description":"The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had 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.","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":"NUMBER","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":"Incidence Ulcerative Mucositis (WHO Grades 2, 3, and 4)","type":"SECONDARY","unitOfMeasure":"participants"}