Research Article

Perampanel Monotherapy for Focal and Generalized Epilepsy in Clinical Practice

Table 2

Summary of safety and tolerability (tolerability population).

Total PWE

PWE with any AE, (%)89 (45.2)
Most frequently reported AEs, (%)
 Dizziness/vertigo33 (16.8)
 Irritability22 (11.2)
 Somnolence18 (9.1)
 Depression13 (6.6)
PWE with AEs leading to discontinuation (12 months), (%)18 (13.7)
Types of AEs leading to discontinuation (12 months), (%)
 Depression10 (7.6)
 Dizziness/vertigo8 (6.1)
 Irritability8 (6.1)
 Somnolence5 (3.8)
 Instability/ataxia4 (3.1)
 Confusion1 (0.8)
 Dry mouth1 (0.8)
PWE with any psychiatric AE, (%)41 (20.8)
PWE with psychiatric AEs who discontinued§, (%)17 (10.2)
Types of psychiatric AEs in PWE who discontinued§, (%)
 Depression10 (6.0)
 Irritability8 (4.8)

≥5% of PWE; ; §these PWE had psychiatric AEs, but it was not possible to determine if it was these AEs that led to discontinuation; ; AE: adverse event; PWE: people with epilepsy.