Table 4 Summary of treatment-emergent adverse events (safety population)
| Â | All patients | |||
|---|---|---|---|---|
|  | LEV (n = 151) | Standard AEDs (n = 152) | VPA-ER (n = 49) | CBZ-CR (n = 103) |
Summary of adverse events, n (%) | ||||
 ≥1 TEAE | 115 (76.2) | 118 (77.6) | 33 (67.3) | 85 (82.5) |
 Drug-related AEs | 70 (46.4) | 93 (61.2) | 29 (59.2) | 64 (62.1) |
 Severe AEsa | 31 (20.5) | 22 (14.5) | 4 (8.2) | 18 (17.5) |
 Serious AEs | 28 (18.5) | 13 (8.6) | 2 (4.1) | 11 (10.7) |
 Serious drug-related AEs | 3 (2.0) | 4 (2.6) | 1 (2.0) | 3 (2.9) |
 AEs leading to discontinuation | 17 (11.3) | 41 (27.0) | 5 (10.2) | 36 (35.0) |
 Deaths | 2 (1.3) | 1 (0.7) | 0 | 1 (1.0) |
Drug-related TEAEs reported by ≥ 5 % of patients in any treatment group, n (%) | ||||
 Fatigue | 17 (11.3) | 33 (21.7) | 9 (18.4) | 24 (23.3) |
 Dizziness | 10 (6.6) | 16 (10.5) | 0 | 16 (15.5) |
 Somnolence | 8 (5.3) | 9 (5.9) | 2 (4.1) | 7 (6.8) |
 Headache | 8 (5.3) | 7 (4.6) | 0 | 7 (6.8) |
 Nausea | 4 (2.6) | 11 (7.2) | 1 (2.0) | 10 (9.7) |
 Weight gain | 4 (2.6) | 11 (7.2) | 6 (12.2) | 5 (4.9) |
 Tremor | 1 (0.7) | 9 (5.9) | 7 (14.3) | 2 (1.9) |
 Constipation | 1 (0.7) | 6 (3.9) | 0 | 6 (5.8) |
 Rash | 0 | 8 (5.3) | 0 | 8 (7.8) |