Table 3.
Overview of safety outcomes among pediatric patients who received perampanel as adjunctive treatment.
| Total (N = 34) |
Responders (n = 19) |
Non-responders (n = 13) |
|
|---|---|---|---|
| All AEs, n (%) | 15 (44.12) | 8 (42.11) | 5 (38.46) |
| AEs leading to perampanel dose adjustment, n (%) | 4 (12.50) | 2 (10.53) | —— |
| Withdrawal | 3 (8.82) | 1 (5.26) | —— |
| Somnolence | 1 (2.94) | —— | —— |
| Drooling | 1 (2.94) | 1 (5.26) | —— |
| Irritability | 1 (2.94) | —— | —— |
| Dose reduction | 1 (2.94) | 1 (5.26) | —— |
| Unconsciousness | 1 (2.94) | 1 (5.26) | —— |
| AEs, n (%) | |||
| Aggression | 5 (14.70) | 3 (15.79) | 2 (15.38) |
| Dizziness | 3 (8.82) | 2 (10.53) | 1 (7.69) |
| Fatigue | 2 (5.88) | 1 (5.26) | 1 (7.69) |
| Weight gain | 2 (5.88) | 1 (5.26) | 1 (7.69) |
| Nausea | 2 (5.88) | 1 (5.26) | 1 (7.69) |
| Somnolence | 2 (5.88) | 1 (5.26) | 1 (7.69) |
| Gait problems | 2 (5.88) | 1 (5.26) | —— |
| Drooling | 1 (2.94) | 1 (5.26) | —— |
| Unconsciousness | 1 (2.94) | 1 (5.26) | |
| Hyperactivity | 1 (2.94) | —— | 1 (7.69) |
| Depression | 1 (2.94) | —— | —— |
| Irritability | 1 (2.94) | —— | —— |
| Baseline ASMs received by patients with AEs, n (%) | |||
| Topiramate | 7 (20.59) | 3 (15.79) | 3 (23.08) |
| Valproate | 7 (20.59) | 5 (26.32) | 1 (7.69) |
| Lacosamide | 5 (14.71) | 4 (21.05) | 1 (7.69) |
| Oxcarbazepine | 4 (11.76) | 2 (10.53) | 2 (15.38) |
| Levetiracetam | 4 (11.76) | 3 (15.79) | —— |
| Nitrazepam | 3 (8.82) | 2 (10.53) | 1 (7.69) |
AEs = adverse events, ASM = anti-seizure medication.