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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