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Xigris Study Halted in Children With Sepsis
A numerical increase in the rate of central nervous system (CNS) bleeding in the Xigris versus the placebo group was also noted. Over the infusion period the number of patients experiencing an intracranial hemorrhage event was 4 versus 1 for the overall population (Xigris vs. placebo), with 3 of the 4 events in the Xigris group occurring in patients aged 60 days or less.
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Source: The Food and Drug Administration