Table 5.

Serious bleeding events by study day in primary efficacy population

	Alternative therapy		Standard therapy
Time period	Severe (n = 33) 30 to 36 μg/kg/hr	Moderate (n = 173) 24 μg/kg/hr	Severe (n = 51) 24 μg/kg/hr	Moderate (n = 176) 24 μg/kg/hr
Days 0 to 4	0	9 (4 GI, catheter, renal, hematoma, hemoptysis, hepatic)	0	2 (GI)
Days 5 to 8	0	3*† (CNS, pleural, shock)	1 (hemoptysis)	0
Days 9 to 28	0	1‡ (hepatic)	0	1† (CNS)
After day 28	0	1† (CNS)	0	0
Total	0	14§	1	3

*Patients completed the study drug infusion per protocol - event occurred on the same day (n = 1; pleural hemorrhage) or day after (n = 2; cerebral hemorrhage; shock hemorrhage) infusion was completed. ^†CNS bleeds: cerebral hemorrhage Day 7 (n = 1), cerebral hematoma Day 11 (n = 1), cerebral hemorrhage Day 32 (n = 1). ^‡Fatal bleeds: arterial hemorrhage (hepatic) Day 24 following surgery, not study related (n = 1). ^§One patient experienced two events on Day 2 and Day 7. CNS, central nervous system; GI, gastrointestinal