Table 2.
Pooled incidence rates of adverse events occurring in ⩾5% of patients in any treatment group across the perampanel phase III trials [Steinhoff et al. 2013, 2014c].
| Perampanel |
|||||
|---|---|---|---|---|---|
| Adverse event, n (%) | Placebo (n = 442) | 2 mg (n = 180) | 4 mg (n = 172) | 8 mg (n = 431) | 12 mg (n = 255) |
| Any adverse event | 294 (66.5) | 111 (61.7) | 111 (64.5) | 350 (81.2) | 227 (89.0) |
| Dizziness | 40 (9.0) | 18 (10.0) | 28 (16.3) | 137 (31.8) | 109 (42.7) |
| Somnolence | 32 (7.2) | 22 (12.2) | 16 (9.3) | 67 (15.5) | 45 (17.6) |
| Headache | 50 (11.3) | 16 (8.9) | 19 (11.0) | 49 (11.4) | 34 (13.3) |
| Fatigue | 21 (4.8) | 8 (4.4) | 13 (7.6) | 36 (8.4) | 31 (12.2) |
| Irritability | 13 (2.9) | 7 (3.9) | 7 (4.1) | 29 (6.7) | 30 (11.8) |
| Nausea | 20 (4.5) | 4 (2.2) | 5 (2.9) | 25 (5.8) | 20 (7.8) |
| Fall | 15 (3.4) | 2 (1.1) | 3 (1.7) | 22 (5.1) | 26 (10.2) |
| Nasopharyngitis | 18 (4.1) | 7 (3.9) | 9 (5.2) | 23 (5.3) | 11 (4.3) |
| Upper respiratory tract Infection | 12 (2.7) | 11 (6.1) | 6 (3.5) | 14 (3.2) | 10 (3.9) |
| Ataxia | 0 (0.0) | 0 (0.0) | 1 (0.6) | 14 (3.2) | 21 (8.2) |
| Balance disorder | 2 (0.5) | 0 (0.0) | 0 (0.0) | 22 (5.1) | 8 (3.1) |