TABLE 2.
Characteristics of the safety population, N = 163
| Variable | Value |
|---|---|
| Baseline demographics | |
| Age, years | |
| Mean (SD) | 23.1 (15.1) |
| Median (range) | 18.0 (6–65) |
| 6–11 years, n (%) | 45 (27.6) |
| ≥12 years, n (%) | 118 (72.4) |
| Sex, n (%) | |
| Male | 74 (45.4) |
| Female | 89 (54.6) |
| Race, n (%) | |
| White | 134 (82.2) |
| Black/African American | 16 (9.8) |
| Asian | 4 (2.5) |
| Native Hawaiian/Pacific Islander | 5 (3.1) |
| Other | 4 (2.5) |
| Height, mean (SD), cm | 151.6 (24.8) a |
| Weight, mean (SD), kg | 60.2 (33.6) b |
| During study | |
| Exposure | |
| Mean days (SD) | 528.7 (251.7) |
| Median days (range) | 458 (56–1230) |
| <6 months, n (%) | 9 (5.5) |
| 6–<12 months, n (%) | 21 (12.9) |
| ≥12 months, n (%) | 133 (81.6) |
| Number of doses per month, mean (SD) | 2.3 (1.5) |
| Range | 1–10 |
| Number of doses per patient, mean (SD) | 26.9 (42.5) |
| Range | 1–356 |
| Doses administered, total | 4390 |
| Seizure clusters treated | 3853 |
| Concomitant benzodiazepine use during study, n (%) | |
| Yes | 125 (76.7) |
| No | 38 (23.3) |
| Presence of seasonal allergies/rhinitis, n (%) | |
| Yes | 70 (42.9) |
| No | 93 (57.1) |
a
n = 159.
b
n = 162.