Table 2.
Adverse events by treatment group (all causalities) in the double-blind trial
| Pregabalin (N = 54) | Placebo (N = 53) | |
|---|---|---|
| AEs, n | 167 | 132 |
| Patients with AEs, n (%) | 38 (70.4) | 34 (64.2) |
| Patients with serious AEs, n (%) | 1 (1.9) | 0 |
| Patients with severe AEs, n (%) | 3 (5.6) | 3 (5.7) |
| Discontinuations due to AEs, n (%) | 4 (7.4) | 4 (7.5) |
| Common AEsa, n (%) | ||
| Dizziness | 16 (29.6) | 7 (13.2) |
| Nausea | 12 (22.2) | 5 (9.4) |
| Headache | 10 (18.5) | 10 (18.9) |
| Weight increased | 9 (16.7) | 0 (0.0) |
| Fatigue | 8 (14.8) | 4 (7.5) |
| Somnolence | 5 (9.3) | 2 (3.8) |
| Oropharyngeal pain | 4 (7.4) | 2 (3.8) |
| Pain in extremity | 4 (7.4) | 0 (0.0) |
| Pyrexia | 4 (7.4) | 3 (5.7) |
| Back pain | 3 (5.6) | 5 (9.4) |
| Upper respiratory tract infection | 3 (5.6) | 4 (7.5) |
| Vomiting | 3 (5.6) | 4 (7.5) |
AE adverse event
a Occurring in at least 5 % of subjects taking pregabalin