Outcomes
ADVERSE EVENTS
The primary outcomes were treatment‐emergent adverse events (TEAEs), reported spontaneously by the patient and/or caregiver or observed by the investigator, and discontinuations due to TEAEs. Other safety outcomes included changes in 12‐lead electrocardiograms (ECGs), vital sign measurements (blood pressure and pulse rate), physical examinations, and neurological examinations. The Safety Set (SS) was defined as all patients who received at least one dose of lacosamide (oral and/or IV) in this open‐label trial. The SS‐IV was defined as all patients in the SS who received at least one dose of IV lacosamide and was the primary analysis set for the safety data.