Table 2.
TEAEs for psychiatric disorders occurring in ≥3 patients in any treatment groupa: double‐blind phase III partial‐seizure studies
| TEAE (MedDRA preferred termb) | Placeboc(N = 442) n (%) | Perampanelc | ||||
|---|---|---|---|---|---|---|
| 2 mg/day (N = 180) n (%) | 4 mg/day (N = 172) n (%) | 8 mg/day (N = 431) n (%) | 12 mg/day (N = 255) n (%) | Total (N = 1,038) n (%) | ||
| Patients with any TEAE | 55 (12.4) | 17 (9.4) | 11 (6.4) | 74 (17.2) | 57 (22.4) | 159 (15.3) |
| Insomnia | 16 (3.6) | 2 (1.1) | 2 (1.2) | 15 (3.5) | 11 (4.3) | 30 (2.9) |
| Anxiety | 5 (1.1) | 4 (2.2) | 3 (1.7) | 13 (3.0) | 9 (3.5) | 29 (2.8) |
| Aggression | 2 (0.5) | 1 (0.6) | 1 (0.6) | 7 (1.6) | 8 (3.1) | 17 (1.6) |
| Anger | 1 (0.2) | 0 | 0 | 5 (1.2) | 7 (2.7) | 12 (1.2) |
| Depression | 7 (1.6) | 1 (0.6) | 1 (0.6) | 3 (0.7) | 6 (2.4) | 11 (1.1) |
| Sleep disorder | 1 (0.2) | 2 (1.1) | 1 (0.6) | 6 (1.4) | 2 (0.8) | 11 (1.1) |
| Nervousness | 3 (0.7) | 1 (0.6) | 0 | 6 (1.4) | 2 (0.8) | 9 (0.9) |
| Confusional state | 2 (0.5) | 1 (0.6) | 1 (0.6) | 3 (0.7) | 4 (1.6) | 9 (0.9) |
| Mood swings | 3 (0.7) | 1 (0.6) | 0 | 5 (1.2) | 2 (0.8) | 8 (0.8) |
| Depressed mood | 4 (0.9) | 2 (1.1) | 0 | 4 (0.9) | 1 (0.4) | 7 (0.7) |
| Mood altered | 2 (0.5) | 0 | 1 (0.6) | 2 (0.5) | 4 (1.6) | 7 (0.7) |
| Euphoric mood | 0 | 0 | 0 | 1 (0.2) | 4 (1.6) | 5 (0.5) |
| Agitation | 2 (0.5) | 0 | 0 | 3 (0.7) | 1 (0.4) | 4 (0.4) |
| Apathy | 2 (0.5) | 0 | 0 | 3 (0.7) | 0 | 3 (0.3) |
a
A patient with ≥2 adverse events with the same preferred term is counted only once for that preferred term.
b
MedDRA preferred terms are sorted in descending order of frequency in the total perampanel column.
c
Patients treated during the double‐blind study. Dose groups are based on the actual treatment groups.
MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment‐emergent adverse event.