Table 1.
No. of patients (%) | |||
Event | Placebo (n = 840) | Drotrecogin alfa (activated) (n = 850) | P value |
Gastrointestinal bleeding | 9 (1.1) | 9 (1.1) | |
Intra-abdominal bleeding | 4 (0.5) | 3 (0.4) | |
Intrathoracic bleeding | 1 (0.1) | 6 (0.7) | |
Retroperitoneal bleeding | 0 | 4 (0.5) | |
Intracranial bleeding | 1 (0.1) | 2 (0.2) | |
Skin or soft tissue bleeding | 0 | 2 (0.2) | |
Genitourinary bleeding | 0 | 2 (0.2) | |
Unidentified source bleeding | 2 (0.2) | 2 (0.2) | |
Total serious bleeding events | 17 (2.0) | 30 (3.5) | 0.06 |
Thrombotic events | 25 (3.0) | 17 (2.0) | 0.2 |
*From reference 9.
PROWESS indicates the Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis.