Table 1.
Demographics and Characteristics (Safety Analysis Set)
| CBDV (N=81) | Placebo (N=81) | |
|---|---|---|
| Sex | ||
| Male, N (%) | 34 (42) | 38 (47) |
| Female, N (%) | 47 (58) | 43 (53) |
| Race | ||
| White/Caucasian, N (%) | 80 (99) | 81 (100) |
| Asian, N (%) | 1 (1) | 0 |
| Age (years), mean (SD) | 36.0 (11) | 36.1 (13) |
| Weight (kg), mean (SD) | 69.7 (17) | 73.8 (19) |
| Country | ||
| Czech Republic, N (%) | 10 (12) | 13 (16) |
| Hungary, N (%) | 13 (16) | 11 (14) |
| Poland, N (%) | 50 (62) | 48 (59) |
| Spain, N (%) | 4 (5) | 4 (5) |
| United Kingdom, N (%) | 4 (5) | 5 (6) |
| Baseline focal seizure frequency, mean (SD) | 38.7 (54) | 41.7 (74) |
| Baseline seizure frequency | ||
| Type 1, mean (SD)a | 33.5 (64) [N=34] | 25.5 (35) [N=42] |
| Type 2, mean (SD)a | 23.8 (30) [N=66] | 30.9 (72) [N=62] |
| Type 3, mean (SD)a | 11.0 (12) [N=38] | 12.9 (25) [N=30] |
| Type 4, mean (SD)a | 16.5 (36) [N=9] | 8.1 (19) [N=10] |
a
Type 1: focal seizures, which did not impair consciousness or awareness and had a motor component; Type 2: focal seizures, which impaired consciousness or awareness; Type 3: focal seizures, which evolved to bilateral convulsive seizures; and Type 4: other (seizures other than those listed above, that is, focal seizures without impairment of consciousness or awareness and without an observable motor component).
CBDV, cannabidivarin; N, number of participants; SD, standard deviation.