Table 12.

Major complications related to study drugs

Relationship to study drug	n	Description	Study arm
Possibly related	1	Painless hematochezia following hard bowel movement (minor)	B
Probably related	1	Hematoma, operative leg, from post-op trauma (minor; delayed discharge)	B
	1	Hematoma evaluated, no intervention required (minor; delayed discharge)	B
Related	1	Hemorrhage with ischemic colitis. INR prolonged on 1 mg warfarin	C
		per day due to VKORC-1 genome disorder. (major; readmitted to hospital)