{"analyses":[{"ciLowerLimit":"0.33","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.26","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":"0.192","paramType":"Hazard Ratio (HR)","paramValue":"0.64","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"comment":"Quartile 3 value is not available because a small number of participants died.","groupId":"OG000","lowerLimit":"35.9","upperLimit":"NA","value":"50.6"},{"comment":"Median and quartile 3 values are not available because a small number of participants died.","groupId":"OG001","lowerLimit":"44.1","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"57"}],"units":"Participants"}],"description":"Overall survival (OS) is based on death from any cause, not just the condition being treated, thus it picks up death from side effects of the treatment, and effects on survival after relapse.","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":"Overall Survival","type":"SECONDARY","unitOfMeasure":"Months"}