Table 4.
Overview of Common Treatment-Emergent AEs (All-Causality Safety Analysis)
| Pregabalin | Placebo | |
|---|---|---|
| N=170 | N=164 | |
| AEs, n | 272 | 217 |
| Patients with AEs, n (%) | 119 (70.0) | 103 (62.8) |
| Patients with serious AEs, n (%) | 0 | 9 (5.5) |
| Patients with severe AEs, n (%) | 16 (9.4) | 15 (9.1) |
| Discontinuations due to AEs, n (%) | 22 (12.9) | 11 (6.7) |
| Dose reduced/temporary discontinuation due to AE, n (%) | 25 (14.7) | 11 (6.7) |
| Common AEsa, n (%) | ||
| Dizziness | 71 (41.8) | 30 (18.3) |
| Somnolence | 30 (17.6) | 13 (7.9) |
| Headache | 10 (5.9) | 10 (6.1) |
| Upper respiratory tract infection | 10 (5.9) | 7 (4.3) |
Note: aIn ≥5% of patients in any treatment group.
Abbreviation: AE, adverse event.