TABLE 2.
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.