Table 5.
Mild Hepatic Impairment (N = 8) | Moderate Hepatic Impairment (N = 8) | Severe Hepatic Impairment (N = 6) | Normal Hepatic Function (N = 8) | |||||
---|---|---|---|---|---|---|---|---|
SOC MedDRA PT | e | n (%) | e | n (%) | e | n (%) | e | n (%) |
Total | 4 | 1 (12.5) | 1 | 1 (12.5) | 0 | 0 | 0 | 0 |
Gastrointestinal disorders | 3 | 1 (12.5) | 0 | 0 | 0 | 0 | 0 | 0 |
Diarrhea | 3 | 1 (12.5) | 0 | 0 | 0 | 0 | 0 | 0 |
Investigations | 0 | 0 | 1 | 1 (12.5) | 0 | 0 | 0 | 0 |
Platelet count low | 0 | 0 | 1 | 1 (12.5) | 0 | 0 | 0 | 0 |
Nervous system disorders | 1 | 1 (12.5) | 0 | 0 | 0 | 0 | 0 | 0 |
Dizziness | 1 | 1 (12.5) | 0 | 0 | 0 | 0 | 0 | 0 |
e, number of times the adverse event occurred; MedDRA PT, Medical Dictionary for Regulatory Activities preferred term; N, number of subjects exposed; n, number of subjects that experienced the AE; SOC, system organ class.