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Table 2 Most Frequently Reported Adverse Events and Elevated Serum Liver Function Tests in African American and Caucasian Subjects

From: African American patients with gout: efficacy and safety of febuxostat vs allopurinol

  African American N = 228 Caucasian N = 1863 p valuea
Total subjects reporting ≥ 1 AE, n (%) 115 (50.4) 1052 (56.5) 0.090
Most frequently reported AEs, n (%)    
   Liver function analyses 8 (3.5) 141 (7.6) 0.020
   Upper respiratory tract infections 15 (6.6) 141 (7.6) 0.689
   Diarrhea 10 (4.4) 128 (6.9) 0.202
   Musculoskeletal and connective tissue signs and symptoms 9 (3.9) 89 (4.8) 0.739
   Joint related signs and symptoms 7 (3.1) 69 (3.7) 0.851
Elevated liver function tests, n/N (%)    
   ALT    
≥ 2X ULN 5/206 (2) 172/1737 (10) < 0.001
≥ 3X ULN 1/206 (< 1) 50/1737 (3) 0.037
   AST    
≥ 2X ULN 8/206 (4) 93/1736 (5) 0.505
≥ 3X ULN 3/206 (1) 24/1736 (1) 0.760
  1. AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal
  2. a p values are from Fisher's exact test
  3. AEs are reported by MedDRA High Level Term. Most frequent events are those occurring in at least 3 percent of African American subjects.