Table 6

Incidence of treatment-emergent AEs ≥5% in any of the treatment groups (safety population)

Incidence of TEAEs, n (%)
Standard AEDs (N=841)VPA stratumCBZ stratum
TEAELEV (N=835)LEV (N=345)VPA-ER (N=342)LEV (N=489)CBZ-CR (N=499)
Headache161 (19.3)170 (20.2)60 (17.4)58 (17.0)101 (20.7)112 (22.4)
Fatigue120 (14.4)134 (15.9)46 (13.3)39 (11.4)74 (15.1)95 (19.0)
Dizziness68 (8.1)70 (8.3)23 (6.7)18 (5.3)45 (9.2)52 (10.4)
Somnolence68 (8.1)48 (5.7)29 (8.4)13 (3.8)39 (8.0)35 (7.0)
Weight increased47 (5.6)98 (11.7)21 (6.1)65 (19.0)26 (5.3)33 (6.6)
Nausea44 (5.3)57 (6.8)12 (3.5)18 (5.3)32 (6.5)39 (7.8)
Depression43 (5.1)20 (2.4)21 (6.1)7 (2.0)22 (4.5)13 (2.6)
Vertigo40 (4.8)36 (4.3)24 (7.0)11 (3.2)16 (3.3)25 (5.0)
Nasopharyngitis40 (4.8)46 (5.5)16 (4.6)14 (4.1)24 (4.9)32 (6.4)
Diarrhoea38 (4.6)39 (4.6)19 (5.5)19 (5.6)19 (3.9)20 (4.0)
Weight decreased29 (3.5)19 (2.3)21 (6.1)8 (2.3)8 (1.6)11 (2.2)
Tremor14 (1.7)43 (5.1)4 (1.2)32 (9.4)10 (2.0)11 (2.2)
Alopecia11 (1.3)23 (2.7)6 (1.7)18 (5.3)5 (1.0)5 (1.0)
Rash9 (1.1)29 (3.4)009 (1.8)29 (5.8)
  • Note: one patient who received LEV was not randomised and therefore not assigned to a stratum. This patient is not included in the by-stratum AE counts.

  • AED, antiepileptic drug; CBZ, carbamazepine; CBZ-CR, controlled-release carbamazepine; LEV, levetiracetam; TEAE, treatment-emergent adverse event; VPA, sodium valproate; VPA-ER, extended-release sodium valproate.