Table 4.
TEAEs, SAEs, and TEAEs leading to discontinuation (narrow & broad SMQs for hostility/aggression)a: 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 (%) | ||
| Any TEAE | 25 (5.7) | 9 (5.0) | 9 (5.2) | 53 (12.3) | 52 (20.4) | 123 (11.8) |
| Irritability | 13 (2.9) | 7 (3.9) | 7 (4.1) | 29 (6.7) | 30 (11.8) | 73 (7.0) |
| Aggressiond | 2 (0.5) | 1 (0.6) | 1 (0.6) | 7 (1.6) | 8 (3.1) | 17 (1.6) |
| Skin laceration | 7 (1.6) | 1 (0.6) | 0 | 7 (1.6) | 6 (2.4) | 14 (1.3) |
| Angerd | 1 (0.2) | 0 | 0 | 5 (1.2) | 7 (2.7) | 12 (1.2) |
| Agitation | 2 (0.5) | 0 | 0 | 3 (0.7) | 1 (0.4) | 4 (0.4) |
| Abnormal behavior | 0 | 0 | 0 | 2 (0.5) | 2 (0.8) | 4 (0.4) |
| Laceration | 0 | 0 | 0 | 2 (0.5) | 1 (0.4) | 3 (0.3) |
| Affect lability | 0 | 0 | 0 | 0 | 2 (0.8) | 2 (0.2) |
| Personality change | 1 (0.2) | 0 | 0 | 1 (0.2) | 0 | 1 (0.1) |
| Psychotic disorder | 1 (0.2) | 0 | 0 | 1 (0.2) | 0 | 1 (0.1) |
| Belligerenced | 0 | 0 | 0 | 0 | 1 (0.4) | 1 (0.1) |
| Disinhibition | 0 | 0 | 0 | 1 (0.2) | 0 | 1 (0.1) |
| Hypomania | 0 | 0 | 0 | 1 (0.2) | 0 | 1 (0.1) |
| Impulse‐control disorder | 0 | 0 | 0 | 0 | 1 (0.4) | 1 (0.1) |
| Injury | 0 | 0 | 0 | 0 | 1 (0.4) | 1 (0.1) |
| Personality disorder | 0 | 0 | 0 | 1 (0.2) | 0 | 1 (0.1) |
| Physical assaultd | 0 | 0 | 1 (0.6) | 0 | 0 | 1 (0.1) |
| Psychomotor hyperactivity | 0 | 0 | 0 | 1 (0.2) | 0 | 1 (0.1) |
| Any treatment‐emergent SAE | 1 (0.2) | 1 (0.6) | 0 | 2 (0.5) | 4 (1.6) | 7 (0.7) |
| Aggression | 0 | 1 (0.6) | 0 | 0 | 2 (0.8) | 3 (0.3) |
| Psychotic disorder | 1 (0.2) | 0 | 0 | 1 (0.2) | 0 | 1 (0.1) |
| Belligerence | 0 | 0 | 0 | 0 | 1 (0.4) | 1 (0.1) |
| Impulse‐control disorder | 0 | 0 | 0 | 0 | 1 (0.4) | 1 (0.1) |
| Skin laceration | 0 | 0 | 0 | 1 (0.2) | 0 | 1 (0.1) |
| Any TEAE leading to discontinuation | 3 (0.7) | 0 | 0 | 4 (0.9) | 13 (5.1) | 17 (1.6) |
| Aggression | 0 | 0 | 0 | 1 (0.2) | 4 (1.6) | 5 (0.5) |
| Irritability | 1 (0.2) | 0 | 0 | 1 (0.2) | 3 (1.2) | 4 (0.4) |
| Anger | 0 | 0 | 0 | 0 | 4 (1.6) | 4 (0.4) |
| Personality change | 1 (0.2) | 0 | 0 | 1 (0.2) | 0 | 1 (0.1) |
| Psychotic disorder | 1 (0.2) | 0 | 0 | 1 (0.2) | 0 | 1 (0.1) |
| Belligerence | 0 | 0 | 0 | 0 | 1 (0.4) | 1 (0.1) |
| Impulse‐control disorder | 0 | 0 | 0 | 0 | 1 (0.4) | 1 (0.1) |
| Skin laceration | 0 | 0 | 0 | 0 | 1 (0.4) | 1 (0.1) |
| Any TEAE leading to dose reduction | 0 | 0 | 0 | 6 (1.4) | 12 (4.7) | 18 (1.7) |
| Irritability | 0 | 0 | 0 | 1 (0.2) | 8 (3.1) | 9 (0.9) |
| Aggression | 0 | 0 | 0 | 4 (0.9) | 2 (0.8) | 6 (0.6) |
| Abnormal behavior | 0 | 0 | 0 | 1 (0.2) | 1 (0.4) | 2 (0.2) |
| Anger | 0 | 0 | 0 | 1 (0.2) | 1 (0.4) | 2 (0.2) |
| Psychomotor hyperactivity | 0 | 0 | 0 | 1 (0.2) | 0 | 1 (0.1) |
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.
d
Narrow SMQ term for hostility/aggression.
MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event; SMQ, standardized MedDRA query; TEAE, treatment‐emergent adverse event.