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Summary of adverse events (AEs) and adverse drug reactions (ADRs).
| AE or ADR | Safety data set (n = 410) |
|---|---|
| n (%) | |
| All AEs | 176 (42.9) |
| Severity of AE | |
| Mild | 162 (39.5) |
| Moderate | 13 (3.2) |
| Severe | 1 (0.2) |
| ≥1% of AEs | |
| Hyperuricemia | 30 (7.3) |
| Hyperlipidemia | 23 (6.8) |
| Dizziness | 12 (2.9) |
| Hepatic dysfunction | 8 (2.0) |
| Headache | 4 (1.0) |
| All ADRs | 40 (9.8) |
| ≥0.7% of ADRs | |
| Dizziness | 8 (2.0) |
| Hyperuricemia | 5 (1.2) |
| Hepatic dysfunction | 3 (0.7) |
| Headache | 3 (0.7) |
| Fatigue | 3 (0.7) |
