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Table 2 Incidence of bleeding events during the treatment period a

From: A randomized, open-label trial of edoxaban in Japanese patients with severe renal impairment undergoing lower-limb orthopedic surgery

 

MiRI

SRI

 

Edoxaban 30 mg

Edoxaban 15 mg

Fondaparinux 1.5 mg

CL CR mL/min

≥50 to ≤80

≥15 to <30

≥15 to <20

≥20 to <30

≥20 to <30

N

30

29 (total)

7

22

20

Any bleeding events

n (%)

10 (33.3)

6 (20.7)

1 (14.3)

5 (22.7)

8 (40.0)

95% CI b

19.2, 51.2

9.8, 38.4

2.6, 51.3

10.1, 43.4

21.9, 61.3

Major or CRNM bleeding

n (%)

2 (6.7)

1 (3.4)

0

1 (4.5)

1 (5.0)

95% CI b

1.8, 21.3

0.6, 17.2

0.0, 35.4

0.8, 21.8

0.9, 23.6

Major bleeding

n (%)

0

0

0

0

0

95% CI b

0.0, 11.4

0.0, 11.7

0.0, 35.4

0.0, 14.9

0.0, 16.1

CRNM bleeding

n (%)

2 (6.7)

1 (3.4)

0

1 (4.5)

1 (5.0)

95% CI b

1.8, 21.3

0.6, 17.2

0.0, 35.4

0.8, 21.8

0.9, 23.6

Minor bleeding

n (%)

10 (33.3)

5 (17.2)

1 (14.3)

4 (18.2)

7 (35.0)

95% CI b

19.2, 51.2

7.6, 34.5

2.6, 51.3

7.3, 38.5

18.1, 56.7

  1. CI = confidence interval; CRNM = clinically relevant non-major; MiRI = mild renal impairment; SRI = severe renal impairment.
  2. aSafety analysis set; bScore method.
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Thrombosis Journal

ISSN: 1477-9560

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