Table 2.

Serious bleeding rates in clinical trials of drotrecogin alfa (activated)

Study	Placebo n (%)	DAA n (%)	P
PROWESS	17(2.0)	30(3.5)	0.06
PROWESS (CNS)	1(0.1)	2(0.2)	NS
ADDRESS	28(2.2)	51(3.9)	0.01
ADDRESS (Day 0–6)	15(1.2)	31 (2.4)	0.02
ADDRESS (CNS)	5(0.4)	6 (0.5)	0.72
RESOLVE	16(6.8)	16 (6.7)	0.97
RESOLVE (Day 0–6)	8(3.4)	98 (3.8)	0.83
RESOLVE (CNS)	5(2.1)	11 (4.6)	0.13
ENHANCE	–	155 (6.5)	–

Day 0–6: any serious bleeding event occurring during the DAA infusion period

CNS central nervous system bleeding