Table 4.
Summary of common treatment-emergent adverse events (AEs)
| Common AEsa | Treatment-related
|
All causalities
|
||||
|---|---|---|---|---|---|---|
| n (%) | Time to onset, days | Duration, days | n (%) | Time to onset, days | Duration, days | |
| Somnolence | 50 (48.5) | 20.0 | 166.5 | 53 (51.5) | 18.0 | 150.0 |
| Weight gain | 29 (28.2) | 64.0 | 274.0 | 31 (30.1) | 82.0 | 233.0 |
| Dizziness | 23 (22.3) | 5.0 | 70.0 | 24 (23.3) | 5.0 | 63.5 |
| Peripheral edema | 18 (17.5) | 53.5 | 164.0 | 18 (17.5) | 39.5 | 164.0 |
| Feeling abnormal | 7 (6.8) | 1.0 | 15.0 | 7 (6.8) | 1.0 | 15.0 |
| Constipation | 5 (4.9) | 113.0 | 260.0 | 8 (7.8) | 32.5 | 304.5 |
| Thirst | 5 (4.9) | 20.0 | 351.0 | 7 (6.8) | 23.0 | 346.0 |
| Visual acuity reduced | 5 (4.9) | 372.0 | 1.0 | 7 (6.8) | 372.0 | 1.0 |
| Asthenia | 3 (2.9) | 2.0 | 38.0 | 3 (2.9) | 2.0 | 38.0 |
| Fatigue | 3 (2.9) | 18.0 | 134.0 | 4 (3.9) | 30.0 | 169.0 |
| Hyperuricemia | 3 (2.9) | 30.0 | 260.0 | 4 (3.9) | 30.0 | 222.0 |
| Nausea | 3 (2.9) | 1.0 | 12.0 | 3 (2.9) | 1.0 | 12.0 |
| Neutropenia | 3 (2.9) | 258.0 | 8.0 | 3 (2.9) | 258.0 | 8.0 |
| Neutrophil count decreased | 3 (2.9) | 82.0 | 12.0 | 3 (2.9) | 82.0 | 12.0 |
| Vision blurred | 3 (2.9) | 24.0 | 287.0 | 3 (2.9) | 24.0 | 287.0 |
| Renal impairment | 3 (2.9) | 225.0 | 50.0 | 3 (2.9) | 225.0 | 50.0 |
Note:
a
Treatment-related AEs occurring in more than 2% of pregabalin-treated patients.