TABLE 1.
Patient demographics and baseline characteristics
| Characteristic | Value |
|---|---|
| N (OLE safety population) | 247 |
| Age at OLE entry, years, mean (SD) | 14 (8) |
| Age group, years, n (%) | |
| 2 to < 18 | 168 (68.0) |
| 18–36 | 79 (32.0) |
| Sex, male, n (%) | 136 (55.1) |
| Race, n (%) | |
| White | 199 (80.6) |
| Black or African American | 12 (4.9) |
| Asian | 8 (3.2) |
| Other, unknown, or multiple | 8 (3.2) |
| Not reported a | 20 (8.1) |
| Ethnicity, n (%) | |
| Hispanic or Latino | 48 (19.4) |
| Not Hispanic or Latino | 178 (72.1) |
| Not reported a | 21 (8.5) |
| Region, n (%) | |
| North America | 122 (49.4) |
| Europe | 117 (47.4) |
| Australia | 8 (3.2) |
| Baseline frequency of drop seizures per 28 days, median (minimum, maximum) b | 75 (4, 2943) |
| Prior medications, median (range) | 7 (1–20) |
| Concomitant medications, median (range) | 3 (1–7) |
| n (%) | |
| Valproate, all forms | 141 (57.1) |
| Clobazam | 112 (45.3) |
| Lamotrigine | 87 (35.2) |
| Levetiracetam | 57 (23.1) |
| Rufinamide | 52 (21.1) |
| Cannabidiol | 12 (4.9) |
Abbreviation: OLE, open‐label extension.
a
Privacy laws in some regions/countries preclude disclosure of certain personal information.
b
Determined during the core study.