Table 7. Treatment-Emergent Adverse Events by System Organ Class, Preferred Term and Relationship to Treatment (Certain, Probable, Possible) during the 6‐Week Treatment Period (Safety Population).
| System Organ Class Preferred Term and Relationship | Placebo (n = 71) | Polmacoxib 2 mg (n = 147) | Celecoxib 200 mg (n = 144) |
|---|---|---|---|
| Gastrointestinal disorders | 3 (4.2) | 15 (10.2) | 14 (9.7) |
| Certain | 0 | 0 | 1 (0.7) |
| Probable | 1 (1.4) | 4 (2.7) | 2 (1.4) |
| Possible | 1 (1.4) | 2 (1.4) | 1 (0.7) |
| Abdominal pain | 1 (1.4) | 3 (2.0) | 0 |
| Probable | 0 | 1 (0.7) | 0 |
| Abdominal pain, upper | 1 (1.4) | 1 (0.7) | 4 (2.8) |
| Certain | 0 | 0 | 1 (0.7) |
| Probable | 0 | 1 (0.7) | 2 (1.4) |
| Possible | 1 (1.4) | 0 | 1 (0.7) |
| Diarrhea | 0 | 3 (2.0) | 3 (2.1) |
| Probable | 0 | 1 (0.7) | 0 |
| Dyspepsia | 1 (1.4) | 7 (4.8) | 5 (3.5) |
| Probable | 1 (1.4) | 2 (1.4) | 1 (0.7) |
| Possible | 0 | 1 (0.7) | 1 (0.7) |
| Enteritis | 0 | 1 (0.7) | 0 |
| Probable | 0 | 1 (0.7) | 0 |
| Epigastric discomfort | 0 | 1 (0.7) | 0 |
| Possible | 0 | 1 (0.7) | 0 |
| General disorders and administration site conditions | 2 (2.8) | 16 (10.9) | 8 (5.6) |
| Probable | 0 | 2 (1.4) | 1 (0.7) |
| Possible | 0 | 4 (2.7) | 2 (1.4) |
| Face oedema | 1 (1.4) | 3 (2.0) | 2 (1.4) |
| Probable | 0 | 2 (1.4) | 0 |
| Generalized oedema | 0 | 2 (1.4) | 1 (0.7) |
| Probable | 0 | 0 | 1 (0.7) |
| Oedema | 0 | 4 (2.7) | 0 |
| Possible | 0 | 3 (2.0) | 0 |
| Oedema, peripheral | 0 | 7 (4.8) | 3 (2.1) |
| Probable | 0 | 2 (1.4) | 0 |
| Possible | 0 | 1 (0.7) | 2 (1.4) |
| Investigation | 1 (1.4) | 3 (2.0) | 2 (1.4) |
| Possible | 1 (1.4) | 1 (0.7) | 0 |
| Alanine aminotransferase increased | 1 (1.4) | 0 | 0 |
| Possible | 1 (1.4) | 0 | 0 |
| Aspartate aminotransferase increased | 1 (1.4) | 0 | 0 |
| Possible | 1 (1.4) | 0 | 0 |
| Blood creatinine increased | 0 | 1 (0.7) | 0 |
| Possible | 0 | 1 (0.7) | 0 |
| Gamma-glutamyltransferase increased | 1 (1.4) | 0 | 0 |
| Possible | 1 (1.4) | 0 | 0 |
| Nervous system disorders | 0 | 1 (0.7) | 5 (3.5) |
| Possible | 0 | 1 (0.7) | 1 (0.7) |
| Headache | 0 | 1 (0.7) | 2 (1.4) |
| Possible | 0 | 1 (0.7) | 1 (0.7) |
| Somnolence | 0 | 0 | 1 (0.7) |
| Possible | 0 | 0 | 1 (0.7) |
| Psychiatric disorders | 0 | 0 | 1 (0.7) |
| Possible | 0 | 0 | 1 (0.7) |
| Depression | 0 | 0 | 1 (0.7) |
| Possible | 0 | 0 | 1 (0.7) |
| Skin and subcutaneous tissue disorders | 2 (2.8) | 5 (3.4) | 2 (1.4) |
| Possible | 1 (1.4) | 3 (2.0) | 0 (0.0) |
| Pruritus | 1 (1.4) | 1 (0.7) | 1 (0.7) |
| Possible | 0 | 1 (0.7) | 0 |
| Swelling face | 0 | 3 (2.0) | 0 |
| Possible | 0 | 1 (0.7) | 0 |
| Urticaria | 2 (2.8) | 1 (0.7) | 0 |
| Possible | 1 (1.4) | 1 (0.7) | 0 |
Values are presented as number (%).