Table 4 Most common treatment-emergent AE by hepatic function (safety population)
AE, n (%) | Hepatic function | ||||
|---|---|---|---|---|---|
Normal (n = 11) | Mild impairment (n = 17) | Moderate impairment (n = 14) | Severe impairment (n = 4) | Total (N = 46) | |
Any AEa | 10 (90.9) | 17 (100.0) | 14 (100.0) | 4 (100.0) | 45 (97.8) |
Fatigue | 8 (72.7) | 7 (41.2) | 9 (64.3) | 0 (0.0) | 24 (52.2) |
Blood bilirubin increased | 0 (0.0) | 1 (5.9) | 10 (71.4) | 0 (0.0) | 11 (23.9) |
Anemia | 6 (54.5) | 10 (58.8) | 3 (21.4) | 2 (50.0) | 21 (45.7) |
Peripheral edema | 4 (36.4) | 2 (11.8) | 5 (35.7) | 0 (0.0) | 11 (23.9) |
Diarrhea | 4 (36.4) | 4 (23.5) | 4 (28.6) | 1 (25.0) | 13 (28.3) |
Nausea | 3 (27.3) | 5 (29.4) | 5 (35.7) | 0 (0.0) | 13 (28.3) |
Abdominal pain | 0 (0.0) | 3 (17.6) | 5 (35.7) | 1 (25.0) | 9 (19.6) |
Any grade ≥3 AE | 7 (63.6) | 12 (70.6) | 13 (92.9) | 3 (75.0) | 35 (76.1) |
Grade ≥3 AE reported in >3 patients | |||||
Blood bilirubin increased | 0 (0.0) | 0 (0.0) | 10 (71.4) | 0 (0.0) | 10 (21.7) |
Alanine aminotransferase increased | 0 (0.0) | 0 (0.0) | 4 (28.6) | 0 (0.0) | 4 (8.7) |
Anemia | 2 (18.2) | 3 (17.6) | 1 (7.1) | 1 (25.0) | 7 (15.2) |
Fatigue | 2 (18.2) | 3 (17.6) | 2 (14.3) | 0 (0.0) | 7 (15.2) |
Any grade ≥4 AE | 1 (9.1) | 4 (23.5) | 4 (28.6) | 3 (75.0) | 12 (26.1) |
Treatment-related AE | 8 (72.7) | 13 (76.5) | 12 (85.7) | 1 (25.0) | 34 (73.9) |
Treatment-related grade ≥3 AE | 2 (18.2) | 5 (29.4) | 8 (57.1) | 0 (0.0) | 15 (32.6) |
Treatment-related serious AE | 0 (0.0) | 3 (17.6) | 4 (28.6) | 0 (0.0) | 7 (15.2) |