Table 7

Summary of all fatal bleeding events related and unrelated to drotrecogin alfa (activated) in all clinical trials


During infusion period
Post-Infusion Period



Type of event
Drug related (n [%])
Not related (n [%])
Drug related (n [%])
Not related (n [%])

All ICH bleeding
12 (0.4)
4 (0.1)
6 (0.2)
10 (0.4)
Fatal ICH bleeding
7 (0.3)
2 (0.07)
1 (0.04)
7 (0.3)
Fatal non-ICH bleeding
3 (0.1)
0 (0)
0 (0)
0 (0)

A total of 2786 patients treated with drotrecogin alfa (activated) infusion were included in this analysis. ICH, intracranial hemorrhage.

Bernard et al. Critical Care 2003 7:155   doi:10.1186/cc2167