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Table 2 Overview of TEAEs, treatment-related TEAEs, and serious TEAEs

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 experiencing any TEAE, 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)
Overall TEAEs 13 (34.2) 16 (43.2) 16 (41.0) 11 (29.7) 13 (34.2)
 Related to treatment 2 (5.3) 4 (10.8) 2 (5.1) 1 (2.7) 2 (5.3)
 Not related to treatment 11 (28.9) 12 (32.4) 14 (35.9) 10 (27.0) 11 (28.9)
TEAEs by severity
 Mild 7 (18.4) 8 (21.6) 9 (23.1) 6 (16.2) 4 (10.5)
 Moderate 6 (15.8) 7 (18.9) 6 (15.4) 5 (13.5) 7 (18.4)
 Severe 0 1 (2.7) 1 (2.6) 0 2 (5.3)
TEAEs leading to study drug discontinuation 2 (5.3) 0 1 (2.6) 1 (2.7) 0
Serious TEAEs 0 1 (2.7) 1 (2.6) 0 4 (10.5)
 Related to treatment 0 0 0 0 0
 Not related to treatmenta 0 1 (2.7) 1 (2.6) 0 4 (10.5)
 Leading to study drug discontinuation 0 0 0 0 0
Deaths 0 0 0 0 1 (2.6)
  1. Safety analysis set. aSerious TEAEs reported in each of the treatment groups: FBX IR 40 mg, one patient had both gastroenteritis and acute kidney injury; FBX XR 40 mg, one patient had cholelithiasis; FBX XR 80 mg, three patients had coronary artery disease, gangrene, or hypertension and one patient had both sinus node dysfunction and a fatal cardiac arrest
  2. FBX febuxostat, IR immediate release, TEAE treatment-emergent adverse event, XR extended release