Table 3.

Safety Outcomes.^*

Outcome	Milvexian Twice Daily				Milvexian Once Daily			Enoxaparin (N = 296)
	25 mg (N = 148)	50 mg (N = 148)	100 mg (N = 149)	200 mg (N = 148)	25 mg (N = 33)	50 mg (N = 150)	200 mg (N = 147)
Any bleeding — no. (%)	2 (1)	7 (5)	7 (5)	5 (3)	0	8 (5)	9 (6)	12 (4)
Relative risk vs. enoxaparin (95% CI)	0.33 (0.08–1.43)	1.15 (0.47–2.82)	1.14 (0.47–2.80)	0.81 (0.29–2.24)	0 (NA)	1.17 (0.50–2.72)	1.51 (0.66–3.43)	—
Major bleeding or clinically relevant nonmajor bleeding — no. (%)	0	2 (1)	1 (1)	1 (1)	0	2 (1)	1 (1)	5 (2)
Relative risk vs. enoxaparin (95% CI)	0 (NA)	0.79 (0.16–3.96)	0.39 (0.05–3.30)	0.39 (0.05–3.28)	0 (NA)	0.68 (0.14–3.39)	0.40 (0.05–3.34)	—
Major bleeding — no. (%)	0	0	0	0	0	0	0	1 (<1)†
Clinically relevant nonmajor bleeding — no. (%)	0	2 (1)	1 (1)	1 (1)	0	2 (1)	1 (1)	4 (1)
Serious adverse event — no. (%)	5 (3)	5 (3)	5 (3)	2 (1)	1 (3)	2 (1)	2 (1)	11 (4)
At least one adverse event — no. (%)	56 (38)	67 (45)	51 (34)	54 (36)	7 (21)	58 (39)	65 (44)	113 (38)
Adverse event leading to discontinuation of treatment — no. (%)	2 (1)	7 (5)	2 (1)	4 (3)	0	4 (3)	6 (4)	8 (3)

^*Safety outcomes were assessed in the safety population, which included all the patients who had received at least one dose of a trial medication; the time for analysis included the period during which a trial medication was administered plus 2 days. NA denotes not applicable.

^†The patient had a spontaneous subdural hematoma with decreased level of consciousness.