Table 1.

Demographic and Clinical Characteristics of the Patients.^*

Characteristic	Milvexian Twice Daily				Milvexian Once Daily			Enoxaparin†
	25 mg	50 mg	100 mg	200 mg	25 mg	50 mg	200 mg
Modified intention-to-treat population
No. of patients	129	124	134	131	28	127	123	252
Age — yr
Median	69	68	67	69	67	68	68	68
Range	51–87	51–87	50–86	50–86	55–77	50–88	50–88	50–90
Female sex — no. (%)	92 (71)	89 (72)	88 (66)	89 (68)	18 (64)	92 (72)	88 (72)	171 (68)
Race — no. (%)‡
White	112 (87)	107 (86)	117 (87)	116 (89)	28 (100)	103 (81)	105 (85)	216 (86)
Asian	16 (12)	15 (12)	14 (10)	14 (11)	0	21 (17)	15 (12)	29 (12)
Black	1 (1)	1 (1)	3 (2)	1 (1)	0	0	0	3 (1)
Other	0	1 (1)	0	0	0	0	3 (2)	2 (1)
Weight — kg
Median	83	79	85	84	82	80	82	81
Range	40–150	44–150	48–130	42–132	56–134	48–181	48–129	41–146
Baseline creatinine clearance — ml/min§
Median	86	92	90	94	95	88	91	92
Interquartile range	71–109	75–113	70–118	70–114	72–127	70–105	73–115	72–114
Preoperative enoxaparin — no. (%)	8 (6)	9 (7)	8 (6)	7 (5)	2 (7)	10 (8)	11 (9)	28 (11)
Type of anesthesia — no. (%)¶
General	29 (22)	25 (20)	31 (23)	34 (26)	5 (18)	29 (23)	26 (21)	57 (23)
Spinal	99 (77)	99 (80)	102 (76)	96 (73)	23 (82)	101 (80)	99 (80)	194 (77)
Epidural	4 (3)	5 (4)	5 (4)	4 (3)	0	6 (5)	3 (2)	7 (3)
Regional	20 (16)	33 (27)	42 (31)	33 (25)	6 (21)	33 (26)	29 (24)	58 (23)
Other	2 (2)	4 (3)	3 (2)	4 (3)	0	1 (1)	4 (3)	9 (4)
Duration of surgery — hr
Median	1.3	1.4	1.4	1.4	1.4	1.4	1.4	1.4
Range	0.5–3.5	0.7–3.1	0.5–6.6	0.6–2.8	0.8–2.8	0.6–3.3	0.7–3.5	0.4–3.5
Tourniquet use — no. (%)	89 (69)	88 (71)	98 (73)	84 (64)	20 (71)	93 (73)	84 (68)	188 (75)
Duration of tourniquet use — hr
Median	1.2	1.1	1.2	1.1	1.3	1.2	1.3	1.2
Range	0.3–15	0.2–23	0.3–10	0.4–10	0.2–19	0.3–20	0.3–15	0.2–15
Time after surgery to ambulation — days
Median	1	1	1	1	1	1	1	1
Range	0–3	0–3	0–4	0–4	0–4	0–4	0–6	0–4
Baseline factor XI clotting activity — %∥
Median	109	107	104	110	107	100	102	114
Interquartile range	94–127	91–119	93–119	95–124	89–116	87–117	87–113	100–131
Baseline activated partial-thromboplastin time — sec**
Median	26	27	26	26	26	26	26	26
Interquartile range	24–28	25–29	25–28	24–28	25–28	25–29	25–28	25–28
Safety population
No. of patients	148	148	149	148	33	150	147	296
Time after surgery to milvexian or enoxaparin administration — hr
Median	22	22	22	22	22	22	23	22
Range	13–26	13–26	13–25	12–26	13–25	13–26	14–26	7–34
Duration of milvexian or enoxaparin treatment — days
Median	12	12	12	12	12	13	12	12
Range	1–16	2–16	4–17	4–16	9–14	6–16	1–16	1–15

^*The modified intention-to-treat population included all the patients who had received at least one dose of a trial medication and had a venogram within the prespecified time window that could be evaluated, a documented symptomatic venous thromboembolic event, or a fatal event. The safety population included all the patients who had received at least one dose of a trial medication. Percentages may not total 100 because of rounding.

^†Enoxaparin was administered subcutaneously at a dose of 40 mg once daily.

^‡Race was reported by the patient. Three patients in the group receiving 50 mg of milvexian once daily and two in the enoxaparin group chose not to report information on race.

^§Creatinine clearance values were calculated with the use of the Cockcroft and Gault equation.

^¶Patients may have undergone more than one type of anesthesia.

^∥The normal range for factor XI clotting activity is 60 to 150%.

^**The normal range for the activated partial-thromboplastin time is 22 to 29 seconds.