Total no. AE | 59 | 43 | 51 | 80 |
Patients with AE, n (%)* | 33 (32.7) | 27 (27.3) | 28 (28.6) | 44 (43.1) |
Gouty arthritis | 6 (5.9) | 9 (9.1) | 9 (9.2) | 9 (8.8) |
Headache | 5 (5.0) | 4 (4.0) | 3 (3.1) | 4 (3.9) |
Diarrhea | 3 (3.0) | 2 (2.0) | 2 (2.0) | 5 (4.9) |
Dizziness | 2 (2.0) | 1 (1.0) | 2 (2.0) | 6 (5.9) |
Arthralgia | 1 (1.0) | 4 (4.0) | 3 (3.1) | 2 (2.0) |
Upper abdominal pain | 1 (1.0) | 0 (0.0) | 1 (1.0) | 5 (4.9) |
Dyspepsia | 2 (2.0) | 0 (0.0) | 2 (2.0) | 3 (2.9) |
Nausea | 2 (2.0) | 0 (0.0) | 1 (1.0) | 3 (2.9) |
Pain in extremity | 0 (0.0) | 1 (1.0) | 3 (3.1) | 1 (1.0) |
Pyrexia | 4 (4.0) | 1 (1.0) | 0 (0.0) | 0 (0.0) |
Patients with severe AE, n (%) | 5 (5.0) | 3 (3.0) | 2 (2.0) | 1 (1.0) |
Patients with serious AE, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.0) |
Discontinuations due to AE, n (%) | 5 (5.0) | 3 (3.0) | 1 (1.0)** | 9 (8.8)** |
Worsening of gout/gouty arthritis | 2 (2.0) | 3 (3.0) | 1 (1.0) | 2 (2.0) |
Other | 3 (3.0) | 0 (0.0) | 0 (0.0) | 7 (6.8) |
Dose reduced/temporary discontinuations due to AE, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.0) |
Deaths, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |