Table 6.
TEAEs affecting ≥5% of patients in any ESL dose group (ITT population, all periods)
| TEAE; n (%) | ESL 1200 mg (n = 58) | ESL 1600 mg (n = 114) | Total (n = 172) |
|---|---|---|---|
| Headache | 11 (19.0) | 32 (28.1) | 43 (25.0) |
| Dizziness | 6 (10.3) | 24 (21.1) | 30 (17.4) |
| Nasopharyngitis | 4 (6.9) | 9 (7.9) | 13 (7.6) |
| Nausea | 6 (10.3) | 7 (6.1) | 13 (7.6) |
| Somnolence | 2 (3.4) | 10 (8.8) | 12 (7.0) |
| Fatigue | 4 (6.9) | 6 (5.3) | 10 (5.8) |
| Back pain | 3 (5.2) | 6 (5.3) | 9 (5.2) |
| Insomnia | 4 (6.9) | 3 (2.6) | 7 (4.1) |
| Complex partial seizures | 1 (1.7) | 6 (5.3) | 7 (4.1) |
| Influenza | 3 (5.2) | 1 (0.9) | 4 (2.3) |
| Anxiety | 3 (5.2) | 1 (0.9) | 4 (2.3) |
TEAE = treatment-emergent adverse event; ESL = eslicarbazepine acetate; ITT = intention-to-treat.