TABLE 2.
Incidence of TEAEs during the treatment period (SS)
| Patients, n (%) |
Lacosamide overall (N = 106) |
|---|---|
| Any TEAEs | 61 (57.5) |
| Drug‐related TEAEsa | 7 (6.6) |
| Serious TEAEs | 14 (13.2) |
| Severe TEAEs | 10 (9.4) |
| Discontinuations due to TEAEs | 1 (0.9) |
| Deaths | 1 (0.9) |
| TEAEsb occurring in ≥2% of all patients | |
| Headache | 10 (9.4) |
| Nasopharyngitis | 8 (7.5) |
| Back pain | 5 (4.7) |
| Arthralgia | 4 (3.8) |
| Cough | 4 (3.8) |
| Diarrhea | 4 (3.8) |
| Hypertension | 4 (3.8) |
| Cataract | 3 (2.8) |
| Influenza | 3 (2.8) |
| Musculoskeletal pain | 3 (2.8) |
| Osteoarthritis | 3 (2.8) |
| Upper abdominal pain | 3 (2.8) |
| Upper respiratory tract infection | 3 (2.8) |
| Other significant TEAEsb | |
| Atrial flutter | 1 (0.9) |
| Sinus bradycardia | 1 (0.9) |
| Ventricular tachycardia | 1 (0.9) |
Abbreviations: SS, Safety Set; TEAE, treatment‐emergent adverse event.
a
Drug‐related TEAEs were those with a relationship of “related” or those with missing responses.
b
Preferred Term (Medical Dictionary for Regulatory Activities, version 16.1).