Table 3 Incidence of clinical adverse experiences (AEs), by study period.
| 12‐Week part I of base studies | 40‐Week part II of base studies | 86‐Week extension period | ||||||
|---|---|---|---|---|---|---|---|---|
| Placebo (n = 112) | Etoricoxib (n = 446) | Naproxen (n = 439) | Etoricoxib (n = 434) | Naproxen (n = 404) | Etoricoxib (n = 246) | Naproxen (n = 217) | ||
| Any AE | 57 (50.9) | 262 (58.7) | 279 (63.6) | 301 (69.4) | 276 (68.3) | 179 (72.8) | 181 (83.4) | |
| Serious AEs | 1 (0.9) | 6 (1.3) | 9 (2.1) | 32 (7.4) | 30 (7.4) | 26 (10.6) | 33 (15.2) | |
| Discontinuations due to AEs | 9 (8.0) | 24 (5.4) | 44 (10.0) | 37 (8.5) | 46 (11.4) | 24 (9.8) | 28 (12.9) | |
| Drug related AEs | 19 (17.0) | 96 (21.5) | 128 (29.2) | 76 (17.5) | 91 (22.5) | 42 (17.1) | 58 (26.7) | |
| Most common AEs (⩾5.0% in any treatment group) | ||||||||
| Abdominal pain | 2 (1.8) | 7 (1.6) | 22 (5.0) | 8 (1.8) | 10 (2.5) | 2 (0.8) | 11 (5.1) | |
| Influenza‐like disease | 2 (1.8) | 13 (2.9) | 13 (3.0) | 27 (6.2) | 13 (3.2) | 5 (2.0) | 11 (5.1) | |
| Upper respiratory infection | 6 (5.4) | 34 (7.6) | 35 (8.0) | 47 (10.8) | 43 (10.6) | 33 (13.4) | 18 (8.3) | |
| Hypertension | 7 (6.3) | 23 (5.2) | 13 (3.0) | 32 (7.4) | 17 (4.2) | 27 (11.0) | 23 (10.6) | |
| Dyspepsia | 2 (1.8) | 9 (2.0) | 22 (5.0) | 11 (2.5) | 11 (2.7) | 6 (2.4) | 5 (2.3) | |
| Epigastric discomfort | 3 (2.7) | 13 (2.9) | 24 (5.5) | 13 (3.0) | 17 (4.2) | 6 (2.4) | 9 (4.1) | |
| Heartburn | 4 (3.6) | 12 (2.7) | 23 (5.2) | 10 (2.3) | 10 (2.5) | 4 (1.6) | 4 (1.8) | |
| Nausea | 4 (3.6) | 14 (3.1) | 23 (5.2) | 8 (1.8) | 4 (1.0) | 3 (1.2) | 4 (1.8) | |
| Sinusitis | 2 (1.8) | 9 (2.0) | 7 (1.6) | 8 (1.8) | 15 (3.7) | 13 (5.3) | 12 (5.5) | |
| Back pain | 6 (5.4) | 3 (0.7) | 6 (1.4) | 21 (4.8) | 12 (3.0) | 15 (6.1) | 13 (6.0) | |
| Bronchitis | 1 (0.9) | 9 (2.0) | 6 (1.4) | 14 (3.2) | 12 (3.0) | 11 (4.5) | 12 (5.5) | |
| Urinary tract infection | 0 (0.0) | 14 (3.1) | 11 (2.5) | 21 (4.8) | 20 (5.0) | 13 (5.3) | 18 (8.3) | |
Results are shown as No (%).