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Table 3 Most common TEAEs (reported by ≥ 5% of patients in any treatment group)

From: Efficacy and safety of febuxostat extended release and immediate release in patients with gout and moderate renal impairment: phase II placebo-controlled study

  Patients reporting any TEAEs (by system organ class/preferred term), n (%)
  Placebo (n = 38) FBX IR 40 mg (n = 37) FBX XR 40 mg (n = 39) FBX IR 80 mg (n = 37) FBX XR 80 mg (n = 38)
Cardiac disorders
 Palpitations 0 0 2 (5.1) 0 0
Gastrointestinal disorders
 Diarrhea 0 2 (5.4) 0 0 0
Infections and infestations
 Gastroenteritis 0 2 (5.4) 0 0 0
 Urinary tract infection 0 2 (5.4) 0 0 0
Metabolism and nutrition disorders
 Hyperglycemia 0 0 2 (5.1) 0 0
Renal and urinary disorders
 Renal failure 2 (5.3) 0 0 0 0
Vascular disorders
 Hypertension 1 (2.6) 1 (2.7) 0 1 (2.7) 4 (10.5)
  1. Safety analysis set
  2. FBX febuxostat, IR immediate release, TEAE treatment-emergent adverse event, XR extended release