TEAE by treatment group (all causalities). Values are n (%) unless otherwise specified.
| Variables | Pregabalin, n = 181 | Placebo, n = 177 |
|---|---|---|
| Total no. TEAE | 468 | 245 |
| Patients with TEAE | 140 (77.3) | 106 (59.9) |
| Patients with SAE | 3 (1.7) | 1 (0.6) |
| Discontinuation because of TEAE | 11 (6.1) | 6 (3.4) |
| TEAE in ≥ 5% of patients | ||
| Dizziness | 51 (28.2) | 12 (6.8) |
| Somnolence | 36 (19.9) | 8 (4.5) |
| Constipation | 19 (10.5) | 4 (2.3) |
| Nausea | 17 (9.4) | 12 (6.8) |
| Diarrhea | 16 (8.8) | 7 (4.0) |
| Weight increased | 16 (8.8) | 3 (1.7) |
| Headache | 14 (7.7) | 17 (9.6) |
| Insomnia | 13 (7.2) | 1 (0.6) |
| Dry mouth | 12 (6.6) | 1 (0.6) |
| Fatigue | 12 (6.6) | 8 (4.5) |
| Nasopharyngitis | 5 (2.8) | 10 (5.6) |
TEAE: treatment-emergent adverse event; SAE: serious adverse event.