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Table 4 Characteristics of DrotAA-treated adults with PF, MEN, or MD and experienced a serious bleeding event

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

Characteristic

During infusion

After infusion

Relative day of event onset1

1

1

2

3

5

6

6

7

11

18

Bleeding event

          

   ICH

No

No

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

   Fatal

No

No

No

No

Yes

No

No

No

Yes

No

   DrotAA-related2

Yes

No

No

No

Yes

Yes

No

Yes

No

No

Disease category

          

   PF

Yes

Yes

No

No

No

Yes

Yes

No

Yes

Yes

   MEN

No

No

Yes

Yes

Yes

Yes

No

Yes

Yes

No

   MD

Yes

No

Yes

No

No

Yes

No

No

No

Yes

Baseline characteristics

          

   Age (years)

19

20

47

67

73

24

41

77

51

40

   Protein C level (%)

11

NA

11

68

55

79

-

52

-

24

   Platelet count

38

58

154

102

93

30

136

56

11

51

   APTT (s)

198

86.7

65.0

31.1

-

63.0

-

32.0

-

47

   PT (s)

58.9

16.6

-

14.1

-

-

16.3

-

2.6

-

   Organ failure

5

NA

2

1

3

3

-

1

-

4

   APACHE II score

30

NA

20

23

24

26

-

20

-

25

   Hypertension

No

No

No

Yes

Yes

No

No

Yes

No

No

SOFA3

          

   Platelet count

38

NA

70

120

181

34

NA

NA

NA

NA

   Hematology SOFA score

3

NA

2

1

0

3

NA

NA

NA

NA

   Hepatic SOFA score

1

NA

1

0

-

2

NA

NA

NA

NA

   Renal SOFA score

2

NA

2

0

0

0

NA

NA

NA

NA

  1. 1Day 0 is defined as the calendar day on which DrotAA treatment began; 2this denotes whether or not the investigator considered the bleeding event to be related to DrotAA treatment; 3values reported are those obtained 1 day before the relative onset day of the ICH. Data available only during first 6 days of enrollment in the PROWESS and ENHANCE trials. APACHE II, acute physiology and chronic health evaluation II; APTT, activated partial thromboplastin time; BL, baseline; DrotAA, drotrecogin alfa (activated); ICH, intracranial hemorrhage; MD, meningococcal disease; MEN, meningitis; NA, not available; PC, protein C activity; PF, purpura fulminans; PT, prothrombin time; SOFA, Sequential Organ Failure Assessment. A dash indicates missing data.