| Febuxostat 40 mg daily N = 757 | Febuxostat 80 mg daily N = 756 n (%) | Allopurinol 200/300 mg daily N = 756 |
---|---|---|---|
Total Subjects with ≥ 1 AE | 429 (56.7) | 410 (54.2) | 433 (57.3) |
Total Subjects With at ≥ 1 Serious AE | 19 (2.5) | 28 (3.7) | 31 (4.1) |
Most Frequently (≥ 5%) Reported AEs |  |  |  |
   Upper Respiratory Tract Infections | 71 (9.4) | 53 (7.0) | 57 (7.5) |
   Liver Function Analysis | 63 (8.3) | 52 (6.9) | 50 (6.6) |
   Rash | 44 (5.8) | 42 (5.6) | 55 (7.3) |
   Diarrhea | 45 (5.9) | 47 (6.2) | 57 (7.5) |
   Musculoskeletal and Connective Tissue Signs and Symptoms NEC | 43 (5.7) | 38 (5.0) | 32 (4.2) |
All APTC CV Events | |||
   Number of Subjects with Events | 0 | 3 | 3 |
   Rate (%) | 0.00 | 0.40 | 0.40 |
   95% CI (%) | (0.000, 0.486) | (0.082, 1.155) | (0.082, 1.155) |
APTC Events Summarized by Category | |||
   CV Death | 0 | 0 | 2 (0.26) |
   Nonfatal Myocardial Infarction | 0 | 1 (0.13) | 1 (0.13) |
   Nonfatal Stroke | 0 | 2 (0.26) | 0 |
All Non-APTC Events | |||
   Number of Subjects with Events | 10 | 9 | 7 |
   Rate (%) | 1.32 | 1.19 | 0.93 |
   95% CI (%) | (0.635, 2.416) | (0.546, 2.248) | (0.373, 1.898) |
Non-APTC Events Summarized by Category | |||
   Angina | 2 (0.26) | 0 | 0 |
   Coronary Revascularization | 1 (0.13) | 0 | 1 (0.13) |
   Transient Ischemic Attack | 1 (0.13) | 0 | 1 (0.13) |
   Cerebral Revascularization | 0 | 0 | 0 |
   Venous and Peripheral Arterial Vascular Thrombotic Event | 0 | 2 (0.26) | 0 |
   Congestive Heart Failure | 2 (0.26) | 0 | 1 (0.13) |
   Arrhythmia, No Evidence of Ischemia | 3 (0.40) | 4 (0.53) | 1 (0.13) |
   Other Non-APTC CV Events | 1 (0.13) | 3 (0.40) | 3 (0.40) |