Table 2.
Incidence of exit criteria and predicted exit percentage, FAS
| Lacosamide maintenance phase | Primary efficacy analysis lacosamide 400 mg/day N = 284 n (%) | Exploratory analysis lacosamide 300 mg/day N = 99 n (%) |
|---|---|---|
| Patients meeting at least one exit criterion (patients can be counted under more than one exit criterion) | 82 (28.9) | 26 (26.3) |
| Exit 1: At least a twofold increase in POS frequency seizures per 28 days compared with the baseline phase | 50 (17.6) | 14 (14.1) |
| Exit 2: At least a twofold increase in consecutive 2-day POS frequency compared with the baseline phase | 34 (12.0) | 10 (10.1) |
| Exit 3: Occurrence of a GTCS if none had occurred in the 6 months prior to randomization | 9 (3.2) | 4 (4.0) |
| Exit 4: Prolongation or worsening overall seizure duration, frequency, type, or pattern that necessitated study discontinuation | 23 (8.1) | 8 (8.1) |
| Exit 5: Status epilepticus or new onset of serial/cluster seizures | 5 (1.8) | 1 (1.0) |
| Kaplan-Meier predicted exit percentage at day 112 (95% CI) | 30.0 (24.6, 35.5) | 27.3 (18.4,36.3) |
| Historical-control exit percentage, lower bound for the 95% prediction interval | 65.3 | 65.3 |
POS, partial-onset seizures; FAS, full analysis set; GTCS, generalized tonic–clonic seizures; CI, confidence interval.