{"analyses":[{"ciLowerLimit":"-1.542","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"32.415","groupDescription":"For the secondary endpoints, the type I error rate was protected by using the Hochberg procedure to adjust for multiple testing16. 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":"0.142","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":"15.436","statisticalMethod":"van Elteren test","testedNonInferiority":false},{"ciLowerLimit":"-11.820","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"22.482","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":"5.331","statisticalMethod":"van Elteren test","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"45.04","value":"29.82"},{"groupId":"OG001","spread":"32.35","value":"24.55"},{"groupId":"OG002","spread":"52.90","value":"39.97"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"115"}],"units":"Participants"}],"description":"The mean daily scores were calculated using the subject daily assessment of Patient-reported mouth and throat soreness (MTS) on the 5 point scale with higher values in MTS indicating a worse self assessed MTS. A 5-grade WHO scale (0, 1, 2, 3, or 4). 0=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. 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. The area under the curve were calculated at the time points; Day(D)-2, up to Day 32.","dispersionType":"Standard Deviation","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","reportingStatus":"POSTED","timeFrame":"at Day 32","title":"The Area Under the Curve (AUC) Was Calculated From the Patient-reported Outcome Mouth and Throat Soreness (MTS) Score.","type":"SECONDARY","unitOfMeasure":"units on a scale * days"}