Table 3.
TEAEs occurring in at least 5% of patients in any treatment group (safety analysis set).
| Adverse events | SHR4640 10 mg + febuxostat 80 mg (n = 31) |
SHR4640 10 mg + febuxostat 40 mg (n = 32) |
SHR4640 5 mg + febuxostat 20 mg (n = 30) |
Total (n = 93) |
|---|---|---|---|---|
| Gout flares | 8 (25.8) | 8 (25.0) | 5 (16.7) | 21 (22.6) |
| Increased alanine aminotransferase | 3 (9.7) | 5 (15.6) | 6 (20.0) | 14 (15.1) |
| Diarrhea | 2 (6.5) | 1 (3.1) | 1 (3.3) | 4 (4.3) |
| Upper respiratory tract infection | 0 | 3 (9.4) | 1 (3.3) | 4 (4.3) |
| Increased γ-glutamyltransferase | 0 | 1 (3.1) | 3 (10.0) | 4 (4.3) |
| Hematuria | 3 (9.7) | 0 | 0 | 3 (3.2) |
| Asthenia | 2 (6.5) | 1 (3.1) | 0 | 3 (3.2) |
| Increased blood creatinine | 0 | 1 (3.1) | 2 (6.7) | 3 (3.2) |
| Noninfective gingivitis | 0 | 2 (6.3) | 0 | 2 (2.2) |
| Back pain | 0 | 0 | 2 (6.7) | 2 (2.2) |
| Chest pain | 0 | 0 | 2 (6.7) | 2 (2.2) |
TEAEs, treatment-emergent adverse events.
Data are shown as n (%).