TABLE 2.
Treatment-emergent adverse events
| Adverse eventa | No. (%) of subjects |
||||
|---|---|---|---|---|---|
| Child-Pugh class |
Healthy controls (n = 9) | Hepatically impaired total (n = 24) | |||
| A (n = 8) | B (n = 8) | C (n = 8) | |||
| All subjects with adverse events | 1 (13) | 4 (50) | 4 (50) | 4 (44) | 9 (38) |
| Gastrointestinal disorders | 1 (13) | 4 (50) | 2 (25) | 1 (11) | 7 (29) |
| Diarrhea | 1 (13) | 4 (50) | 2 (25) | 0 (0) | 7 (29) |
| Gastritis | 0 (0) | 0 (0) | 0 (0) | 1 (11) | 0 (0) |
| General disorders and administration site conditions | 0 (0) | 0 (0) | 1 (13) | 0 (0) | 1 (4) |
| Noncardiac chest pain | 0 (0) | 0 (0) | 1 (13) | 0 (0) | 1 (4) |
| Investigations | 0 (0) | 0 (0) | 1 (13) | 1 (11) | 1 (4) |
| Blood creatine phosphokinase increased | 0 (0) | 0 (0) | 1 (13) | 0 (0) | 1 (4) |
| Hepatic enzyme increased | 0 (0) | 0 (0) | 0 (0) | 1 (11) | 0 (0) |
| Nervous system disorders | 0 (0) | 0 (0) | 1 (13) | 2 (22) | 1 (4) |
| Headache | 0 (0) | 0 (0) | 1 (13) | 2 (22) | 1 (4) |
| Skin and subcutaneous tissue disorders | 0 (0) | 0 (0) | 0 (0) | 1 (11) | 0 (0) |
| Rash | 0 (0) | 0 (0) | 0 (0) | 1 (11) | 0 (0) |
Adverse events are classified according to MedDRA version 15.1.