TABLE 1.
Demographics and History, Intention-to-Treat Population
| Characteristic | LCM, n = 37 | fPHT, n = 37 | Total, n = 74 | |
|---|---|---|---|---|
| Age, yr | ||||
| Mean, SD | 63.8 (12.1) | 63.4 (20.4) | 63.6 (16.6) | |
| ≥60 years | 25 (67.6%) | 23 (62.2%) | 48 (64.9%) | |
| Gender, F | 17 (45.9%) | 21 (56.8%) | 38 (51.4%) | |
| Race | ||||
| White | 26 (70.3%) | 32 (86.5%) | 58 (78.4%) | |
| Black or African American | 9 (24.3%) | 3 (8.1%) | 12 (16.2%) | |
| Asian | 2 (5.4%) | 2 (5.4%) | 4 (5.4%) | |
| Neurologic history, concurrent conditionsa | 26 (70.3%) | 20 (54.1%) | 46 (62.2%) | |
| Subdural hemorrhage | 6 (16.2%) | 5 (13.5%) | 11 (14.9%) | |
| Brain tumor, intra-axial | 3 (8.1%) | 3 (8.1%) | 6 (8.1%) | |
| Hemorrhagic stroke, intraparenchymal | 3 (8.1%) | 2 (5.4%) | 5 (6.8%) | |
| Subarachnoid hemorrhage | 2 (5.4%) | 3 (8.1%) | 5 (6.8%) | |
| Toxic/metabolic encephalopathy | 2 (5.4%) | 1 (2.7%) | 3 (4.1%) | |
| Other | 3 (8.1%) | 6 (16.2%) | 9 (12.2%) | |
| History of status epilepticus | 3 (8.6%) | 0 | 3 (4.2%) | |
| History of provoked seizures | 2 (5.4%) | 1 (2.7%) | 3 (4.1%) | |
| History of epilepsy | 11 (29.7%) | 12 (32.4%) | 23 (31.1%) | |
| Focal onset | 6 (54.5%) | 8 (66.7%) | 14 (60.9%) | |
| Generalized onset | 1 (9.1%) | 2 (16.7%) | 3 (13.0%) | |
| Unknown | 4 (36.4%) | 4 (33.3%) | 8 (34.8%) | |
| Witnessed seizure activity prior to subject’s current illness | 7 (63.6%) | 6 (50.0%) | 13 (56.5%) |
a
Subjects may have had one or more of these conditions
F = female; fPHT = fosphenytoin; LCM = lacosamide; SD = standard deviation