Table 3.
Adverse events (all-causality) experienced by ≥ 2% of patients in either treatment group by preferred term: safety analysis populationa
| No. (%) of patients with adverse events (treatment related) by preferred term | Pregabalin (N = 274) No. (%) | Placebo (N = 265) No. (%) |
|---|---|---|
| Dizziness | 40 (14.6) | 11 (4.2) |
| Somnolence | 27 (9.9) | 9 (3.4) |
| Fatigue | 14 (5.1) | 10 (3.8) |
| Nausea | 14 (5.1) | 8 (3.0) |
| Headache | 12 (4.4) | 8 (3.0) |
| Vertigo Back pain Disturbance in attention |
12 (4.4) 8 (2.9) 8 (2.9) |
1 (0.4) 5 (1.9) 0 |
| Memory impairment Nasopharyngitis Constipation |
7 (2.6) 7 (2.6) 6 (2.2) |
0 8 (3.0) 4 (1.5) |
| Sedation Pain in extremity Insomnia |
6 (2.2) 2 (0.7) 2 (0.7) |
0 6 (2.3) 6 (2.3) |
aIncludes data up to 999 days after last dose of study drug. Medical Dictionary for Regulatory Activities (MedDRA) v18.1) coding dictionary applied