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Table 5 Serious bleeding events by study day in primary efficacy population

From: Randomized trial evaluating serial protein C levels in severe sepsis patients treated with variable doses of drotrecogin alfa (activated)

 

Alternative therapy

Standard therapy

Time period

Severe (n = 33)

30 to 36 μg/kg/hr

Moderate (n = 173)

24 μg/kg/hr

Severe (n = 51)

24 μg/kg/hr

Moderate (n s= 176)

24 μg/kg/hr

Days 0 to 4

0

9 (4 GI, catheter, renal, hematoma, hemoptysis, hepatic)

0

2 (GI)

Days 5 to 8

0

3* (CNS, pleural, shock)

1 (hemoptysis)

0

Days 9 to 28

0

1 (hepatic)

0

1 (CNS)

After day 28

0

1 (CNS)

0

0

Total

0

14§

1

3

  1. *Patients completed the study drug infusion per protocol - event occurred on the same day (n = 1; pleural hemorrhage) or day after (n = 2; cerebral hemorrhage; shock hemorrhage) infusion was completed. CNS bleeds: cerebral hemorrhage Day 7 (n = 1), cerebral hematoma Day 11 (n = 1), cerebral hemorrhage Day 32 (n = 1). Fatal bleeds: arterial hemorrhage (hepatic) Day 24 following surgery, not study related (n = 1). §One patient experienced two events on Day 2 and Day 7. CNS, central nervous system; GI, gastrointestinal