Drotrecogin alfa (activated) in patients with severe sepsis presenting with purpura fulminans, meningitis, or meningococcal disease: a retrospective analysis of patients enrolled in recent clinical studies

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.

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