Table 2

Summary of causes of death in placebo-controlled clinical trials1


Drotrecogin alfa (activated; n [%])
Placebo (n [%])

Cause of death category


Sepsis-induced multiorgan failure
113 (47.9)
107 (39.2)
Refractory septic shock
49 (20.8)
65 (23.8)
Respiratory failure
32 (13.6)
51 (18.7)
Myocardial infarction
9 (3.8)
11 (4.0)
Primary cardiac arrhythmia
6 (2.5)
9 (3.3)
Hemorrhage
4 (1.7)
1 (0.4)
Intracranial hemorrhage
2 (0.8)
1 (0.4)
Stroke
2 (0.8)
7 (2.6)
Other
19 (8.1)
21 (7.7)
Total deaths
236 (100)
273 (100)

The drotrecogin alfa (activated) groups comprised 940 and the placebo groups 881, yielding a total of 1821 patients. 1 F1K-MC-EVAA and F1K-MC-EVAD (PROWESS).

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