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One serious bleeding event occurred during the infusion period in each group.
This incidence rate (0.8%) was similar to the serious bleeding event rate observed during the infusion period for placebo treated patients in controlled studies (0.7%; 6/881).
Approximately 0.4% of drotrecogin alfa (activated) patients experienced a serious bleeding event associated with a fatal outcome that was considered related to its use during the infusion period.
The serious bleeding event rate associated with drotrecogin alfa (activated) was similar across classes of trials (controlled, open-label, and compassionate-use; Table 3).
The overall serious bleeding event rate (5.3%) includes compassionate-use trials, in which investigators had limited experience using drotrecogin alfa (activated).
Neither APACHE II score (< 25 or ≥ 25) nor concomitant heparin use appear to alter serious bleeding event rates associated with drotrecogin alfa (activated) substantially.
Similar(51)
This is an autoimmune disorder characterized by low platelet counts in the blood, which can lead to serious bleeding events.
Still, prescribing blood-thinners alone or in combination can be tricky, since preventing the formation of stroke-inducing clots can also increase the risk of serious bleeding events that require hospitalization and blood transfusions.
Of these, 80 (76.9%) were serious bleeding events, 10 (9.6%) were thrombotic events and 19 (18.3%) were other events.
On day 1 there were 12 patients with nonprocedure-related serious bleeding events.
Three patients experienced non-ICH serious bleeding events associated with a fatal outcome.
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