TABLE 2.
Patient disposition (post hoc efficacy population)
| Patients, n (%) | Levetiracetam trial N159 | Lacosamide trial SP0969 | ||||
|---|---|---|---|---|---|---|
| Placebo (N = 95) | Levetiracetam (N = 98) | All patients (N = 193) | Placebo (N = 166) | Lacosamide (N = 167) | All patients (N = 333) | |
| Discontinued during titration | 7 (7.4) | 4 (4.1) | 11 (5.7) | 8 (4.8) | 10 (6.0) | 18 (5.4) |
| Reached nth seizure during maintenance | 74 (77.9) | 72 (73.5) | 146 (75.6) | 130 (78.3) | 111 (66.5) | 241 (72.4) |
| Completed maintenance without reaching nth seizure | 13 (13.7) | 19 (19.4) | 32 (16.6) | 27 (16.3) | 44 (26.3) | 71 (21.3) |
| Discontinued during maintenance without reaching nth seizure | 1 (1.1) | 3 (3.1) | 4 (2.1) | 1 (0.6) | 2 (1.2) | 3 (0.9) |
| Patients with event (primary analysis a ) | 81 (85.3) | 76 (77.6) | 157 (81.3) | 138 (83.1) | 121 (72.5) | 259 (77.8) |
| Patients with event (secondary analysis b ) | 82 (86.3) | 79 (80.6) | 161 (83.4) | 139 (83.7) | 123 (73.7) | 262 (78.7) |
a
Patients who discontinued during titration were analyzed as efficacy failures on day 1 of the maintenance period, and patients who discontinued during the maintenance period without reaching their nth seizure were censored at the end of their maintenance period.
b
Patients who discontinued during titration were analyzed as efficacy failures on day 1 of the maintenance period, and patients who discontinued during their maintenance period without reaching their nth seizure were analyzed as efficacy failures.