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Serious bleeding and mortality rates in adult severe sepsis patients treated with drotrecogin alfa (activated) |
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| 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) |
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| SBEs during infusion |
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| 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 |
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| 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 |
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| 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 |
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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. | |||||
Vincent et al. Critical Care 2005 9:R331 doi:10.1186/cc3538 |
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