TABLE 4.
Summary of AEs up to 24 Hours after Last Dose of Study Drug, Safety Population
| LCM, n = 35 | fPHT, n = 37 | Total, = 72 | p | |
|---|---|---|---|---|
| Patients with at least 1 TEAE after initial study drug | 9 (25.7%) | 9 (24.3%) | 18 (25.0%) | 1.0 |
| Patients with at least 1 TEAE after crossover study drug: LCM group, n = 15; fPHT group, n = 10 | 5 (33.3%) | 1 (10.0%) | 6 (24.0%) | |
| Patients with at least 1 SAE after initial study drug | 5 (14.3%) | 4 (10.8%) | 9 (12.5%) | 0.73 |
| Patients with at least 1 SAE after crossover study drug: LCM group, n = 15; fPHT group, n = 10 | 3 (20.0%) | 1 (10.0%) | 4 (16.0%) | |
| Patients with TEAE of special interest after initial study druga | 4 (11.4%) | 5 (13.5%) | 9(12.5%) | 1.0 |
| Patients with TEAE of special interest after crossover study drug: LCM group, n = 15; fPHT group, n = 10a | 5 (33.3%) | 2 (20.0%) | 7 (28.0%) | |
| Patients who discontinued treatment with initial study drug due to AE | 2 (5.7%) | 3 (8.1%) | 5 (6.9%) | 1.0 |
| Patients who discontinued treatment with crossover study drug due to AE: LCM group, n = 15; fPHT group, n = 10 | 3 (20.0%) | 0 | 3 (12.0%) |
a
TEAEs of special interest are: cardiac arrhythmias, hypotension, respiratory failure, and multiorgan hypersensitivity reactions.
AE = adverse event; fPHT = fosphenytoin; LCM = lacosamide; SAE = serious AE; TEAE = treatment emergent AE.