Table 6 AEs and ADRs occurring in ≥ 2% of patients (safety analysis set)
|  | Mirogabalin add-on group (N = 63) | Conventional treatment group (N = 65) |
|---|---|---|
AEs | ||
Overall AEs | 24 (38.1) | 8 (12.3) |
 Dizziness | 8 (12.7) | 0 (0.0) |
 Somnolence | 5 (7.9) | 0 (0.0) |
 Urticaria | 2 (3.2) | 0 (0.0) |
Serious AEs | 5 (7.9) | 3 (4.6) |
Discontinuation due to AEs | 5 (7.9) | 0 (0.0) |
 Urticaria | 2 (3.2) | 0 (0.0) |
ADRs | ||
Overall ADRs | 15 (23.8) | 0 (0.0) |
 Dizziness | 8 (12.7) | 0 (0.0) |
 Somnolence | 5 (7.9) | 0 (0.0) |
Serious ADRs | 0 (0.0) | 0 (0.0) |
Discontinuation due to ADRs | 3 (4.8) | 0 (0.0) |