Table 2.
Serious bleeding and mortality rates in adult severe sepsis patients treated with drotrecogin alfa (activated)
| Period and type of event1 | No PF, MEN, or MD (n = 3,088) | PF, MEN, or MD (n = 163) | PF (n = 70) | MEN (n = 106) | MD (n = 80) |
| SBEs during infusion | |||||
| All events, % (n); 95% CI | 3.2 (100); 2.6–3.9 | 3.7 (6); 1.4–7.8 | 4.3 (3); 1.0–12.0 | 3.8 (4); 1.0–9.4 | 3.8 (3); 0.8–10.6 |
| Fatal, % (n) | 0.4 (12) | 0.6 (1) | 0 | 0.9 (1) | 0 |
| Life-threatening, % (n) | 1.4 (43) | 1.2 (2) | 1.4 (1) | 0.9 (1) | 0 |
| ICH, % (n) | 0.4 (13) | 2.5 (4) | 1.4 (1) | 3.8 (4) | 2.5 (2) |
| SBEs over 28 days | |||||
| All events, % (n); 95% CI | 5.8 (178); 5.0–6.6 | 6.1 (10); 3.0–11.0 | 8.6 (6); 3.2–17.7 | 5.7 (6); 2.1–11.9 | 3.8 (3); 0.8–10.6 |
| Fatal, % (n) | 0.8 (24) | 0.6 (1) | 0 | 0.9 (1) | 0 |
| Life-threatening, % (n) | 2.6 (81) | 2.5 (4) | 4.3 (3) | 1.9 (2) | 0 |
| ICH, % (n) | 1.0 (32) | 4.3 (7) | 4.3 (3) | 5.7 (6) | 2.5 (2) |
| 28-day mortality | |||||
| Mortality, % (n); 95% CI | 25.5 (788); 24.0–27.1 | 19.0 (31); 13.3–26.0 | 21.4 (15); 12.5–32.9 | 17.9 (19); 11.2–26.6 | 8.8 (7); 3.6–17.2 |
1 Patients lost to follow-up (No PF, MEN, or MD = 3; PF, MEN, or MD = 2) were excluded from this analysis. DrotAA, drotrecogin alfa (activated); ICH, intracranial hemorrhage; MD, meningococcal disease; MEN, meningitis; PF, purpura fulminans; SBE, serious bleeding event.