Table 2.

Bleeding events for the 28-day study (period) in clinical trials evaluating DrotAA in severe sepsis

	All bleeding events (%)			Serious bleeding events (%)			CNS bleeding (%)
Study	DrotAA	Placebo	P	DrotAA	Placebo	P	DrotAA	Placebo	P
Adults
Phase II [1]	ND	ND		4.0	5.0	0.99	0	0	NS
PROWESS [2]	ND	ND		3.5	2.0	0.06	0.2	0	NS
ENHANCE [11]	ND	NA		6.5	NA		1.5	NA	NA
ADDRESS [12]	ND	ND		3.9	2.2	0.01	0.5	0.4	NS
XPRESS [13]a	12.4	10.9	0.32	3.9	5.2	0.16	1.0	0.7	0.49
Children
Phase Ib [14]	20.5	NA		4.8	NA		2.4	NA	NA
RESOLVE [15]	ND	ND		6.7	6.8	0.97	4.6	2.1	0.13

^aFor the XPRESS trial all patients received drotecogin alfa (activated; DrotAA). Placebo refers to absence of concomitant heparin prophylaxis during DrotAA infusion. ADDRESS, Administration of Drotrecogin alfa (activated) in early stage Severe Sepsis; ENHANCE, Extended Evaluation of Recombinant Human Activated Protein C; NA, not applicable; ND, not described; PROWESS, Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis; RESOLVE, REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspective; XPRESS, Xigris and Prophylactic hepaRin Evaluation in Severe Sepsis.