{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"57"}],"units":"Participants"}],"description":"All comparisons for the long-term safety endpoints were based on the combined palifermin group versus placebo (placebo over palifermin). Incidence of new or secondary malignancies by treatment group was provided (incidence of new or secondary malignancies at the follow-up visit - yes, no, no assessment -, and number of subjects with new or secondary malignancies, per type of malignancies). The long-term safety evaluations were summarized for the subgroups defined by the factors used for randomization using descriptive statistics.","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":"NUMBER","populationDescription":"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":"Incidence of Second Primary Malignancies or Other Malignancies","type":"SECONDARY","unitOfMeasure":"participants"}