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