{"analyses":[{"ciLowerLimit":"0.58","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.23","groupDescription":"All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.372","paramType":"Hazard Ratio, log","paramValue":"0.84","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.4","upperLimit":"24.0","value":"15.1"},{"groupId":"OG001","lowerLimit":"11.9","upperLimit":"27.5","value":"18.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"57"}],"units":"Participants"}],"description":"For the analysis of time to disease progression, competing risks time-to-event analysis was used, since a subject destined to develop disease progression could die from unrelated causes before the disease progression event takes place. Kaplan-Meier survival estimates, with death due to other causes than progression considered as a competing risk, were provided: event rate at 3 month intervals, with 95% confidence interval, the number of subjects at risk at the beginning of the time period, and the number of events of interest.","dispersionType":"Inter-Quartile Range","groups":[{"description":"Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)","id":"OG000","title":"Palifermin (Palifermin Before Only and, Before and After)"},{"description":"Subjects to receive matched placebo before- and after-high dose chemotherapy","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.","reportingStatus":"POSTED","timeFrame":"During long-term follow up phase (maximum of 10 years)","title":"Time Death or Disease Progression","type":"SECONDARY","unitOfMeasure":"months"}