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Table 4 Summary of treatment-emergent adverse events (safety population)

From: Comparative effectiveness of levetiracetam, valproate and carbamazepine among elderly patients with newly diagnosed epilepsy: subgroup analysis of the randomized, unblinded KOMET study

  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)
  1. Abbreviations: 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
  2. aSevere AEs were those affecting the patient’s ability to work normally or to carry out usual activities, and those of definite clinical consequence