Table 6.
Serious bleeding and mortality rates in pediatric severe sepsis patients treated with drotrecogin alfa (activated)
| 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 |
| Serious bleeding events during infusion | |||||
| 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 | |||||
| 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 | |||||
| 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 |
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.