Table 3. Most common adverse events in the treatment period by decreasing incidence in the 150-mg group (based on ⩾5% in either lanicemine group) (safety analysis set) (phase IIB study, study 9).
| Preferred term | Lanicemine (100 mg) (n=51) | Lanicemine (150 mg) (n=51) | Placebo (n=50) |
|---|---|---|---|
| Dizziness, n (%) | 25 (49) | 19 (37) | 6 (12) |
| Nausea, n (%) | 5 (10) | 10 (19) | 8 (16) |
| Somnolence, n (%) | 8 (16) | 4 (8) | 2 (4) |
| Blood pressure increased, n (%) | 3 (6) | 4 (8) | 0 (0) |
| Dry mouth, n (%) | 1 (2) | 4 (8) | 2 (4) |
| Hypoesthesia, n (%) | 1 (2) | 4 (8) | 1 (2) |
| Headache, n (%) | 8 (16) | 3 (6) | 4 (8) |
| Constipation, n (%) | 1 (2) | 3 (6) | 0 (0) |
| Nasopharyngitis, n (%) | 1 (2) | 3 (6) | 0 (0) |
| Diarrhea, n (%) | 4 (8) | 2 (4) | 5 (10) |
| Urinary tract infection, n (%) | 3 (6) | 2 (4) | 4 (8) |
| Upper abdominal pain, n (%) | 4 (8) | 1 (2) | 1 (2) |
| Fatigue, n (%) | 4 (8) | 1 (2) | 0 (0) |
| Sedation, n (%) | 3 (6) | 1 (2) | 1 (2) |