Table 5

Summary of treatment-emergent AEs (safety population)

Patients, n (%)
Standard AEDs (N=841)VPA stratumCBZ stratum
LEV (N=835)LEV (N=345)VPA-ER (N=342)LEV (N=489)CBZ-CR (N=499)
≥1 TEAE587 (70.3)574 (68.3)228 (66.1)212 (62.0)359 (73.4)362 (72.5)
AEs that led to permanent study drug discontinuation69 (8.3)110 (13.1)21 (6.1)16 (4.7)48 (9.8)94 (18.8)
Drug-related AEs381 (45.6)418 (49.7)152 (44.1)157 (45.9)229 (46.8)261 (52.3)
Severe AEs130 (15.6)92 (10.9)46 (13.3)22 (6.4)84 (17.2)70 (14.0)
Serious AEs106 (12.7)61 (7.3)39 (11.3)20 (5.8)67 (13.7)41 (8.2)
Death5 (0.6)3 (0.4)2 (0.6)1 (0.3)3 (0.6)2 (0.4)
  • 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.

  • AE, adverse event; 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.