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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.