Table 4

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

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.

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