Table 3 Adverse events
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 |