Table 3.
Drug‐related treatment‐emergent adverse events (≥2.5%) (SAS)
| Capsaicin 8% patch (n = 282) | Pregabalin (n = 277) | |
|---|---|---|
| Overall (n, %) | 173 (61.3) | 151 (54.5) |
| Application site pain | 67 (23.8) | 0 (0.0) |
| Erythema | 59 (20.9) | 1 (0.4) |
| Burning sensation | 44 (15.6) | 0 (0.0) |
| Application site erythema | 25 (8.9) | 0 (0.0) |
| Pain | 15 (5.3) | 2 (0.7) |
| Headache | 3 (1.1) | 26 (9.4) |
| Abdominal pain upper | 2 (0.7) | 8 (2.9) |
| Nausea | 1 (0.4) | 30 (10.8) |
| Asthenia | 1 (0.4) | 9 (3.2) |
| Dizziness | 0 (0.0) | 51 (18.4) |
| Somnolence | 0 (0.0) | 43 (15.5) |
| Weight increased | 0 (0.0) | 17 (6.1) |
| Vertigo | 0 (0.0) | 14 (5.1) |
| Dry mouth | 0 (0.0) | 13 (4.7) |
| Fatigue | 0 (0.0) | 12 (4.3) |
| Constipation | 0 (0.0) | 12 (4.3) |
| Peripheral oedema | 0 (0.0) | 11 (4.0) |
| Disturbance in attention | 0 (0.0) | 8 (2.9) |
| Diarrhoea | 0 (0.0) | 7 (2.5) |
SAS: Safety analysis set.