Table 3.
Incidence of TEAEsa of any causality with onset during any part of the treatment period, SS
| 400 mg/day N = 319 | 300 mg/day N = 106 | Total N = 425 | |
|---|---|---|---|
| Any TEAE, n (%) | 272 (85.3) | 87 (82.1) | 359 (84.5) |
| Serious TEAE, n (%) | 17 (5.3) | 0 | 17 (4.0) |
| Discontinuations due to TEAE, n (%) | 54 (16.9) | 15 (14.2) | 69 (16.2) |
| Deaths, n (%) | 3 (0.9) | 0 | 3 (0.7) |
| TEAEs occurring in >5% of patients | |||
| Dizziness | 83 (26.0) | 19 (17.9) | 102 (24.0) |
| Headache | 42 (13.2) | 19 (17.9) | 61 (14.4) |
| Nausea | 44 (13.8) | 13 (12.3) | 57 (13.4) |
| Convulsionb | 32 (10.0) | 17 (16.0) | 49 (11.5) |
| Somnolence | 29 (9.1) | 15 (14.2) | 44 (10.4) |
| Fatigue | 32 (10.0) | 11 (10.4) | 43 (10.1) |
| Nasopharyngitis | 25 (7.8) | 7 (6.6) | 32 (7.5) |
| Tremor | 21 (6.6) | 8 (7.5) | 29 (6.8) |
| Diarrhea | 21 (6.6) | 7 (6.6) | 28 (6.6) |
| Vision blurred | 19 (6.0) | 6 (5.7) | 25 (5.9) |
| Insomnia | 17 (5.3) | 7 (6.6) | 24 (5.6) |
| Vomiting | 21 (6.6) | 2 (1.9) | 23 (5.4) |
SS, safety set; TEAE, treatment-emergent adverse event.
a
Coded using Medical Dictionary of Regulatory Activities (MedDRA), Version 9.1.
b
Because the preferred term of convulsions captures both worsening of seizure conditions and improvements (emergence of less severe seizure types), the incidence of convulsion may be an overestimate of the number of patients with worsening seizures.