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Serious bleeding and mortality rates in pediatric severe sepsis patients treated with drotrecogin alfa (activated) |
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| Period and type of event1 |
No PF, MEN, or MD N = 142 |
PF, MEN, or MD N = 119 |
PF N = 85 |
MEN N = 48 |
MD N = 88 |
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| Serious bleeding events during infusion |
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| All events, % (n); 95% CI |
7.0 (10); 3.4–12.6 |
1.7 (2); 0.2–6.0 |
2.4 (2); 0.3–8.2 |
2.1 (1); 0.05–11.1 |
2.3 (2); 0.3–8.0 |
| Fatal, % (n) |
0 |
0 |
0 |
0 |
0 |
| Life-threatening, % (n) |
2.1 (3) |
1.7 (2) |
2.4 (2) |
0 |
2.3 (2) |
| ICH, % (n) |
1.4 (2) |
0 |
0 |
0 |
0 |
| Serious bleeding events over 28 days2 |
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| All events, % (n); 95% CI |
9.2 (13); 5.0–15.2 |
5.9 (7); 2.4–11.7 |
7.1 (6); 2.6–14.7 |
4.2 (2); 0.1–14.3 |
6.8 (6); 2.5–14.3 |
| Fatal, % (n) |
0.7 (1) |
1.7 (2) |
1.2 (1) |
2.1 (1) |
2.3 (2) |
| Life-threatening, % (n) |
2.1 (3) |
3.4 (4) |
4.7 (4) |
0 |
3.4 (3) |
| ICH, % (n) |
3.5 (5) |
2.5 (3) |
2.4 (2) |
2.1 (1) |
2.3 (2) |
| 14-day mortality |
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| Mortality, % (n); 95% CI |
14.1 (20); 8.8–20.9 |
10.1 (12); 5.3–17.0 |
9.4 (8); 4.2–17.7 |
8.3 (4); 2.3–20.0 |
10.2 (9); 4.8–18.5 |
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1Patients lost to follow-up (no PF, MEN, or MD = 1; PF, MEN, or MD = 2) were excluded from this analysis; 2duration of follow-up for the open-label and compassionate-use studies was 28 days, and follow-up for the phase 2b open-label study was 14 days. DrotAA, drotrecogin alfa (activated); ICH, intracranial hemorrhage; MD, meningococcal disease; MEN, meningitis; PF, purpura fulminans. | |||||
Vincent et al. Critical Care 2005 9:R331 doi:10.1186/cc3538 |
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