Table 4.
TEAEs during the titration, maintenance, and treatment periods (safety set).
| Patients, n (%) | Titration period | Maintenance period | Treatment period (titration + maintenance) | |||
|---|---|---|---|---|---|---|
| Placebo (n = 127) |
Lacosamide (n = 128) |
Placebo (n = 125) |
Lacosamide (n = 124) |
Placebo (n = 127) |
Lacosamide (n = 128) |
|
| Any TEAEs | 45 (35.4) | 45 (35.2) | 36 (28.8) | 28 (22.6) | 65 (51.2) | 57 (44.5) |
| Serious TEAEs | 1 (0.8) | 4 (3.1) | 3 (2.4) | 0 | 4 (3.1) | 4 (3.1) |
| Discontinuations due to TEAEs | 0 | 0 | 0 | 2 (1.6) | 0 | 2 (1.6) |
| Drug‐related TEAEs a | 13 (10.2) | 26 (20.3) | 4 (3.2) | 5 (4.0) | 15 (11.8) | 29 (22.7) |
| Drug‐related serious TEAEs a | 0 | 2 (1.6) | 0 | 0 | 0 | 2 (1.6) |
| Severe TEAEs | 0 | 1 (0.8) | 2 (1.6) | 2 (1.6) | 2 (1.6) | 3 (2.3) |
| All deaths (AEs leading to death) | 0 | 0 | 0 | 0 | 0 | 0 |
| Deaths (TEAEs leading to death) | 0 | 0 | 0 | 0 | 0 | 0 |
| TEAEs b reported by ≥5% of patients in either treatment group | ||||||
| Somnolence | 3 (2.4) | 13 (10.2) | 1 (0.8) | 2 (1.6) | 4 (3.1) | 15 (11.7) |
| Irritability | 2 (1.6) | 6 (4.7) | 3 (2.4) | 1 (0.8) | 5 (3.9) | 7 (5.5) |
| Vomiting | 4 (3.1) | 7 (5.5) | 1 (0.8) | 1 (0.8) | 4 (3.1) | 7 (5.5) |
| Pyrexia | 9 (7.1) | 4 (3.1) | 5 (4.0) | 3 (2.4) | 14 (11.0) | 6 (4.7) |
| Upper respiratory tract infection | 10 (7.9) | 2 (1.6) | 2 (1.6) | 1 (0.8) | 11 (8.7) | 3 (2.3) |
AE, adverse event; TEAE, treatment‐emergent adverse event.
a
Related TEAEs were determined as per the investigator.
b
Medical Dictionary for Regulatory Activities v16.1 Preferred Term.