Table 4.
Summary of Adverse Events Among Study Participants
| Moderate Hepatic Impairment | Matched Healthy Controlsa | Overall | |
|---|---|---|---|
| AE, n (%) | (n = 8) | (n = 8) | (n = 16) |
| Participant with any AE | 2 (25) | 3 (38) | 5 (31) |
| Folliculitis | 1 (13) | 0 | 1 (6) |
| Gastroenteritis | 1 (13) | 0 | 1 (6) |
| Upper respiratory tract infectionb | 0 | 1 (13) | 1 (6) |
| Constipationb | 1 (13) | 0 | 1 (6) |
| Hypertensionb | 0 | 1 (13) | 1 (6) |
| Back pain | 0 | 1 (13) | 1 (6) |
| Headacheb | 0 | 1 (13) | 1 (6) |
| Papule | 1 (13) | 0 | 1 (6) |
AE, adverse event.
a
Healthy controls were matched to participants with hepatic impairment by sex, age (±10 years), and body mass index (±25%).
b
Considered related to treatment by study investigator.