Table 3.
Treatment-emergent adverse events occurring in ≥ 5% of subjects in any treatment group (safety population)
| Subjects, n (%) |
|||
|---|---|---|---|
| Placebo (n = 96) | GEn 600 mg (n = 115) | GEn 1200 mg (n = 111) | |
| Adverse event, any | 76 (79.2) | 100 (87.0) | 94 (84.7) |
| Dizziness | 5 (5.2) | 12 (10.4) | 27 (24.3) |
| Somnolence | 2 (2.1) | 25 (21.7) | 20 (18.0) |
| Headache | 8 (8.3) | 17 (14.8) | 15 (13.5) |
| Nasopharyngitis | 7 (7.3) | 13 (11.3) | 11 (9.9) |
| Dry mouth | 2 (2.1) | 5 (4.3) | 9 (8.1) |
| Nausea | 4 (4.2) | 6 (5.2) | 6 (5.4) |
| Sedation | 2 (2.1) | 1 (0.9) | 6 (5.4) |
| Back pain | 3 (3.1) | 6 (5.2) | 3 (2.7) |
| Fatigue | 5 (5.2) | 6 (5.2) | 3 (2.7) |
| Upper respiratory tract infection | 2 (2.1) | 9 (7.8) | 2 (1.8) |
| Sinus congestion | 5 (5.2) | 1 (0.9) | 2 (1.8) |
GEn, gabapentin enacarbil.