Table 5.
Adverse events (all patients, n = 204)
| Number of patients with AE (%) | Weeks 0–52 | Weeks 0–28 (20 mg) | Weeks 28–52 (40 mg) |
|---|---|---|---|
| Any AE | 183 (89.7) | 157 (77.0) | 163 (79.9) |
| AEs leading to discontinuation | 8 (3.9) | 1 (0.5) | 8 (3.9) |
| ADR | 21 (10.3) | 10 (4.9) | 15 (7.4) |
| ADRs leading to discontinuation | 1 (0.5) | 1 (0.5) | 1 (0.5) |
| Serious AE | 12 (5.9) | 4 (2.0) | 11 (5.4) |
| Serious ADR | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Death | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hypoglycemia | 5 (2.5) | 3 (1.5) | 2 (1.0) |
Cases where events continued before and after increased dosage were recorded as one case before and after
ADR adverse drug reaction, AE adverse event