Table 1.
Demographic and Baseline clinical characteristics of patients participating in the Core Study by disease, age, and EIASD cohort (Safety Analysis Set)
| Disease cohort | Age cohort | EIASD cohort | All (total) patients (N = 180) | |||||
|---|---|---|---|---|---|---|---|---|
| FS (N = 149) | FBTCS (N = 54) | GTCS (N = 31) | 4 to <7 years (N = 46) | 7 to <12 years (N = 134) | With EIASDs (N = 48) | Without EIASDs (N = 132)a | ||
| Mean age,b years (SD) | 8.1 (2.1) | 7.7 (2.0) | 8.5 (2.0) | 5.3 (0.7) | 9.1 (1.4) | 8.4 (2.1) | 8.1 (2.1) | 8.1 (2.1) |
| Sex, % | ||||||||
| Female | 52 | 54 | 36 | 52 | 48 | 54 | 47 | 49 |
| Race, n (%) | ||||||||
| Caucasian | 70 (48) | 19 (35) | 23 (89) | 21 (50) | 72 (56) | 30 (64) | 63 (51) | 93 (54) |
| Japanese | 65 (45) | 33 (61) | 0 (0) | 16 (38) | 49 (38) | 13 (28) | 52 (42) | 65 (38) |
| Otherc | 10 (7) | 2 (4) | 3 (12) | 5 (12) | 8 (6) | 4 (9) | 9 (7) | 13 (8) |
| Missing data | 4 | 0 | 5 | 4 | 5 | 1 | 8 | 9 |
| Mean (SD) time since diagnosis,d years | 5.7 (2.7) | 5.7 (2.5) | 5.6 (3.6) | 4.2 (1.5) | 6.2 (3.1) | 5.5 (2.8) | 5.8 (2.9) | 5.7 (2.9) |
| Seizure type,e n (%) | ||||||||
| FS | 148 (99) | 54 (100) | 7 (23) | 41 (89) | 114 (85) | 46 (96) | 109 (83) | 155 (86) |
| Simple FS without motor signs | 19 (13) | 6 (11) | 5 (16) | 5 (11) | 19 (14) | 6 (13) | 18 (14) | 24 (13) |
| Simple FS with motor signs | 46 (31) | 16 (30) | 5 (16) | 9 (20) | 42 (31) | 10 (21) | 41 (31) | 51 (28) |
| Complex FS | 116 (78) | 35 (65) | 4 (13) | 30 (65) | 90 (67) | 38 (79) | 82 (62) | 120 (67) |
| Complex FS with FBTCS | 82 (55) | 54 (100) | 2 (7) | 23 (50) | 61 (46) | 21 (44) | 63 (48) | 84 (47) |
| Generalized seizures | 24 (16) | 9 (17) | 31 (100) | 11 (24) | 44 (33) | 11 (23) | 44 (33) | 55 (31) |
| Absence/myoclonic | 9 (6)/ 12 (8) | 2 (4)/ 3 (6) | 16 (52)/ 17 (55) | 5 (11)/ 6 (13) | 20 (15)/ 23 (17) | 2 (4)/ 4 (8) | 23 (17)/ 25 (19) | 25 (14)/ 29 (16) |
| Clonic/tonic | 6 (4)/ 5 (3) | 3 (6)/ 4 (7) | 10 (32)/ 11 (36) | 4 (9)/ 3 (7) | 12 (9)/ 13 (10) | 2 (4)/ 3 (6) | 14 (11)/ 13 (10) | 16 (9)/ 16 (9) |
| Tonic‐clonic | 4 (3) | 2 (4) | 27 (87) | 6 (13) | 25 (19) | 2 (4) | 29 (22) | 31 (17) |
| Atonic (astatic) | 9 (6) | 4 (7) | 6 (19) | 3 (7) | 12 (9) | 4 (8) | 11 (8) | 15 (8) |
| Number of ASDs at Baseline, n (%) | ||||||||
| EIASDf | ||||||||
| 1 | 13 (28) | 4 (33) | 2 (100) | 1 (9) | 14 (37) | 15 (31) | NA | 15 (31) |
| 2 | 27 (57) | 7 (58) | 0 (0) | 7 (64) | 20 (53) | 26 (54) | NA | 27 (55) |
| 3 | 7 (15) | 1 (8) | 0 (0) | 3 (27) | 4 (11) | 7 (15) | NA | 7 (14) |
| Non‐EIASDsf | ||||||||
| 1 | 14 (14) | 7 (17) | 6 (21) | 4 (11) | 16 (17) | NA | 20 (15) | 20 (15) |
| 2 | 56 (55) | 22 (52) | 17 (59) | 22 (63) | 51 (53) | NA | 73 (56) | 73 (56) |
| 3 | 32 (31) | 13 (31) | 6 (21) | 9 (26) | 29 (30) | NA | 38 (29) | 38 (29) |
Disease cohorts: Patients were assigned as FS or GTCS by the investigator; FBTCS is the subset of FS patients who recorded focal to bilateral tonic‐clonic seizures during the Baseline period. Percentage values may be >100% due to rounding.
Abbreviations: EIASD, enzyme‐inducing anti‐seizure drug; FBTCS, focal to bilateral tonic‐clonic seizures; FS, focal seizures; GTCS, generalized tonic‐clonic seizures; SD, standard deviation.
One patient who was taking carbamazepine for epilepsy at Baseline was erroneously included in the without EIASD cohort.
Age is calculated at date of informed consent/assent.
Not Caucasian and not Japanese race; includes Black or African American, Asian (non‐Japanese), American Indian or Alaska Native, Other.
(Screening date – date of diagnosis)/365.25. If the day or month of diagnosis was missing, the day was imputed as the first of the month, and the month was imputed as January. If imputed date is before the birth date, the birth date was used in place of time from diagnosis.
Multiple seizure types may be recorded.
An EIASD patient took one inducing ASD at Baseline; EIASDs include carbamazepine, oxcarbazepine, eslicarbazepine, and phenytoin; all other ASDs are non‐EIASDs.