Summary of adverse events (AE).
| Adverse Events | Celecoxib, 50 mg bid, n = 101 | Celecoxib, 400/200 mg, n = 99 | Celecoxib, 800/400 mg, n = 98 | Indomethacin 50 mg tid, n = 102 |
|---|---|---|---|---|
| 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) |