Table 7

Characteristics of DrotAA-treated pediatric patients with PF, MEN, or MD and experienced a serious bleeding event

Characteristic

During infusion

After infusion

Day of event¹

1

1

7

8

10

UD

UD

Bleeding event

ICH

No

No

No

Yes

No

Yes

Yes

Fatal

No

No

No

Yes

No

Yes

No

DrotAA related²

No

No

No

Yes

No

No

No

Disease category

PF

Yes

Yes

Yes

Yes

Yes

No

Yes

MEN

No

Yes

No

No

No

Yes

No

MD

Yes

Yes

Yes

Yes

Yes

Yes

No

Baseline characteristics

Protein C level (%)

36

-

16

41

-

34

-

Platelet count

26

23

33

30

68

71

14

APTT (s)

68

165

121

220

73

111

-

PT (s)

23

38

22

-

-

17

16

Organ failure

3

4

3

4

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 treatment with DrotAA. APTT, activated partial thromboplastin time; BL, baseline; DrotAA, drotrecogin alfa (activated); ICH, intracranial hemorrhage; PT, prothrombin time; UD, unknown day after infusion. A dash indicates missing data.

Vincent et al. Critical Care 2005 9:R331   doi:10.1186/cc3538