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Table 3 Adverse events

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
Adverse events
n (%) 22 (73.3) 18 (62.1) 6 (85.7) 12 (54.5) 12 (60.0)
95% CI a 55.6, 85.8 44.0, 77.3 48.7, 97.4 34.7, 73.1 38.7, 78.1
MedDRA preferred term, reported by ≥2 patients, n (%)
Alanine aminotransferase increased 2 (6.7) 3 (10.3) 1 (14.3) 2 (9.1) 0 (0.0)
Aspartate aminotransferase increased 1 (3.3) 5 (17.2) 2 (28.6) 3 (13.6) 0 (0.0)
Blood alkaline phosphatase increased 0 (0.0) 6 (20.7) 1 (14.3) 5 (22.7) 0 (0.0)
Blood bilirubin increased 2 (6.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Blood lactate dehydrogenase increased 0 (0.0) 2 (6.9) 1 (14.3) 1 (4.5) 0 (0.0)
Blood urine present 4 (13.3) 2 (6.9) 0 (0.0) 2 (9.1) 1 (5.0)
Cystitis 2 (6.7) 5 (17.2) 2 (28.6) 3 (13.6) 1 (5.0)
Gamma-glutamyltransferase increased 5 (16.7) 6 (20.7) 2 (28.6) 4 (18.2) 0 (0.0)
Hemorrhage subcutaneous 6 (20.0) 1 (3.4) 0 (0.0) 1 (4.5) 3 (15.0)
Hemoglobin decreased 0 (0.0) 1 (3.4) 1 (14.3) 0 (0.0) 3 (15.0)
Nasopharyngitis 0 (0.0) 2 (6.9) 0 (0.0) 2 (9.1) 1 (5.0)
Red blood cells urine positive 2 (6.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Subcutaneous hematoma 1 (3.3) 3 (10.3) 1 (14.3) 2 (9.1) 0 (0.0)
Urinary tract infection 2 (6.7) 1 (3.4) 0 (0.0) 1 (4.5) 2 (10.0)
Adverse drug reactions
n (%) 13 (43.3) 7 (24.1) 1 (14.3) 6 (27.3) 6 (30.0)
95% CI a 27.4, 60.8 12.2, 42.1 2.6, 51.3 13.2, 48.2 14.5, 51.9
Serious adverse events
n (%) 1 (3.3) 5 (17.2) 3 (42.9) 2 (9.1) 3 (15.0)
95% CI a 0.6, 16.7 7.6, 34.5 15.8, 75.0 2.5, 27.8 5.2, 36.0
Adverse events leading to treatment discontinuation
n (%) 0 2 (6.9) 0 2 (9.1) 1 (5.0)
95% CI a 0.0, 11.4 1.9, 22.0 0.0, 35.4 2.5, 27.8 0.9, 23.6
  1. CI = confidence interval; CLCR = creatinine clearance; MedDRA = medical dictionary for regulatory activities; MiRI = mild renal impairment; SRI = severe renal impairment.
  2. aScore method.