Table 4.
Incidence of TEAEs by baseline AED, age, and dosing subgroups
| N = 571 patients | Any TEAE n (%) | Serious TEAE n (%) | TEAE leading to discontinuation n (%) |
|---|---|---|---|
| Baseline AED | |||
| SCB(+), n = 269a | 124 (46.1) | 23 (8.6) | 24 (8.9) |
| Lamotrigine, n = 134 | 64 (47.8) | 13 (9.7) | 15 (11.2) |
| Carbamazepine, n = 72 | 30 (41.7) | 4 (5.6) | 6 (8.3) |
| Oxcarbazepine, n = 52 | 26 (50.0) | 5 (9.6) | 3 (5.8) |
| SCB(−), n = 313a | 157 (50.2) | 34 (10.9) | 38 (12.1) |
| Levetiracetam, n = 193 | 100 (51.8) | 20 (10.4) | 18 (9.3) |
| Valproate, n = 82 | 37 (45.1) | 12 (14.6) | 14 (17.1) |
| Topiramate, n = 23 | 12 (52.2) | 1 (4.3) | 4 (17.4) |
| Age | |||
| <65 years, n = 461 | 227 (49.2) | 39 (8.5) | 52 (11.3) |
| ≥65 years, n = 110 | 50 (45.5) | 17 (15.5) | 9 (8.2) |
| Maintenance dose | |||
| <200 mg/day, n = 48 | 24 (50.0) | 6 (12.5) | NAa |
| 200–300 mg/day, n = 240 | 104 (43.3) | 21 (8.8) | NAa |
| >300–400 mg/day, n = 161 | 59 (36.6) | 11 (6.8) | NAa |
| >400 mg/day, n = 17 | 12 (70.6) | 4 (23.5) | NAa |
AED, antiepileptic drug; NA, not available; SCB(+), traditional sodium channel blocker; SCB(−), not considered a traditional sodium channel blocker; TEAE, treatment‐emergent adverse event.
Eleven patients belong to both groups.
a
The actual maintenance dose was not calculated for subjects who terminated the study prematurely.