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Table 2 Serious bleeding and mortality rates in adult severe sepsis patients treated with drotrecogin alfa (activated)

From: 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

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. 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.