TABLE 5.
Drug-related adverse events with an incidence of ≥1% in Phase IV studies.
| Drug-related AEs | Phase IV (China mainland) (n = 461) |
|---|---|
| Investigations | |
| Alanine aminotransferase increased | 29 (6.3) |
| Aspartate aminotransferase increased | 21 (4.6) |
| Gamma-glutamyltransferase increased | 10 (2.2) |
| Electrocardiogram - Sinus bradycardia | 6 (1.3) |
| Decreased white blood cells count | 17 (3.7) |
| Neutropeniaa | 19 (4.1) |
| Thrombocytosisb | 9 (2.0) |
| Nervous system disorders | |
| Dizziness | 10 (2.2) |
| Gastrointestinal disorders | |
| Nausea | 28 (6.1) |
| Diarrhea | 7 (1.5) |
| Dry mouth | 5 (1.1) |
| General disorders and administration site conditions | |
| Asthenia | 6 (1.3) |
| Skin and subcutaneous tissue disorders | |
| Pruritus | 5 (1.1) |