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Table 3 Incidence of bleeding events during the treatment period

From: Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V

Event

Edoxaban 30 mg QD (n = 303)

Enoxaparin 2000 IU BID (n = 301)

Absolute difference % (95 % CI)

P

n (%)

95 % CI

n (%)

95 % CI

Major bleeding

2 (0.7)

0.2, 2.4

6 (2.0)

0.9, 4.3

−1.3 (−3.7, 0.7)

0.176

 Subcutaneous hemorrhage

1 (0.3)

NC

2 (0.7)

NC

NC

NC

 Wound hemorrhage

1 (0.3)

-

1 (0.3)

-

-

-

 Duodenal ulcer hemorrhage

0 (0.0)

-

2 (0.7)

-

-

-

 Hemarthrosis

0 (0.0)

-

1 (0.3)

-

-

-

CRNM bleeding

6 (2.0)

0.9, 4.3

5 (1.7)

0.7, 3.8

0.3 (−2.1, 2.8)

0.769

 Subcutaneous hemorrhage

1 (0.3)

NC

0 (0.0)

NC

NC

NC

 Wound hemorrhage

1 (0.3)

-

0 (0.0)

-

-

-

 Conjunctival hemorrhage

1 (0.3)

-

0 (0.0)

-

-

-

 Epistaxis

1 (0.3)

-

0 (0.0)

-

-

-

 Lower gastrointestinal hemorrhage

1 (0.3)

-

0 (0.0)

-

-

-

 Hematuria

1 (0.3)

-

1 (0.3)

-

-

-

 Postprocedural hematoma

0 (0.0)

-

3 (1.0)

-

-

-

 Subcutaneous hematoma

0 (0.0)

-

1 (0.3)

-

-

-

Major or CRNM bleeding

8 (2.6)

1.3, 5.1

11 (3.7)

2.1, 6.4

−1.0 (−4.1, 1.9)

0.475

Minor bleeding

57 (18.8)

14.8, 23.6

39 (13.0)

9.6, 17.2

5.9 (0.0, 11.7)

0.049

Any bleeding

62 (20.5)

16.3, 25.4

48 (15.9)

12.2, 20.5

4.5 (−1.7, 10.7)

0.151

  1. BID, twice daily; CI, confidence interval; CRNM, clinically relevant nonmajor bleeding; IU, international unit; NC, not calculated; QD, once daily
  2. Patients could have multiple bleeds, which were counted individually