Table 7.
Most common all-grade, treatment-emergent, drug-related adverse events (≥10% subjects in total)
| Adverse event [n (%)] | Mild HI (n = 9) | Healthy match, mild HI (n = 10) | Moderate HI (n = 8) | Healthy match, moderate HI (n = 10) | Total (n = 37) |
|---|---|---|---|---|---|
| Headache | 7 (78) | 9 (90) | 5 (63) | 6 (70) | 27 (73) |
| Chills | 8 (89) | 8 (80) | 4 (50) | 6 (60) | 26 (70) |
| Nausea | 5 (56) | 4 (40) | 2 (25) | 4 (40) | 15 (41) |
| Orthostatic hypotension | 3 (33) | 5 (50) | 4 (50) | 2 (20) | 14 (38) |
| Pyrexia | 6 (67) | 4 (40) | 0 | 3 (30) | 13 (35) |
| Tachycardia | 2 (22) | 3 (30) | 2 (25) | 5 (50) | 12 (32) |
| Vomiting | 2 (22) | 4 (40) | 0 | 4 (40) | 10 (27) |
| Influenza-like illness | 1 (11) | 2 (20) | 3 (38) | 3 (30) | 9 (24) |
| Dizziness | 2 (22) | 1 (10) | 1 (13) | 3 (30) | 7 (19) |
| Hypotension | 3 (33) | 1 (10) | 0 | 2 (20) | 6 (16) |
| Myalgia | 2 (22) | 3 (30) | 0 | 0 | 5 (14) |
| Fatigue | 1 (11) | 3 (30) | 0 | 0 | 4 (11) |
| Sinus tachycardia | 1 (11) | 2 (20) | 0 | 1 (10) | 4 (11) |
| Back pain | 2 (22) | 1 (10) | 0 | 1 (10) | 4 (11) |
Abbreviation is as follows: HI, hepatic impairment.