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.