| Celecoxib | Diclofenac SR | ||
| 200 mg once a day | 200 mg twice a day | 75 mg twice a day | |
| (n = 153) | (n = 150) | (n = 155) | |
| Subjects with any TEAEs: | 92 (60.1%) | 68 (45.3%) | 91 (58.7%) |
| No. of events | 180 | 153 | 218 |
| Intensity:* | |||
| Mild | 34 (22.2%) | 24 (16.0%) | 36 (23.2%) |
| Moderate | 43 (28.1%) | 35 (23.3%) | 43 (27.7%) |
| Severe | 15 (9.8%) | 9 (6.0%) | 12 (7.7%) |
| Subjects with drug-related TEAEs | 29 (19.0%) | 31 (20.7%) | 41 (26.5%) |
| Subjects with serious TEAEs | 3 (2.0%) | 2 (1.3%) | 2 (1.3%) |
| Subjects with drug-related serious TEAEs | 1 (0.7%) | 0 | 0 |
| Subjects with premature withdrawal of study medication due to TEAEs | 8 (5.2%) | 12 (8.0%) | 15 (9.7%) |
| Subjects with gastrointestinal TEAEs:† | 23 (15.0%) | 25 (16.7%) | 44 (28.4%) |
| Upper GI TEAEs§ | 10 (6.5%) | 11 (7.3%) | 28 (18.1%) |
| Lower GI TEAEs§ | 9 (5.9%) | 5 (3.3%) | 20 (12.9%) |
| Most common AEs:‡ | |||
| Abdominal distension | 3 (2.0%) | 0 | 1 (0.6%) |
| Abdominal pain NOS | 1 (0.7%) | 1 (0.7%) | 4 (2.6%) |
| Abdominal pain upper | 5 (3.3%) | 5 (3.3%) | 14 (9.0%) |
| Diarrhoea NOS | 6 (3.9%) | 4 (2.7%) | 15 (9.7%) |
| Epigastric discomfort | 0 | 1 (0.7%) | 6 (3.9%) |
| Gastritis NOS | 1 (0.7%) | 4 (2.7%) | 2 (1.3%) |
| Nausea | 0 | 2 (1.3%) | 5 (3.2%) |
| Stomach discomfort | 4 (2.6%) | 1 (0.7%) | 4 (2.6%) |
| Toothache | 4 (2.6%) | 3 (2.0%) | 3 (1.9%) |
| Fatigue | 3 (2.0%) | 3 (2.0%) | 1 (0.6%) |
| Influenza-like illness | 8 (5.2%) | 4 (2.7%) | 2 (1.3%) |
| ALAT increased | 0 | 0 | 6 (3.9%) |
| Arthralgia | 2 (1.3%) | 3 (2.0%) | 0 |
| AS aggravated | 6 (3.9%) | 5 (3.3%) | 2 (1.3%) |
| Dizziness | 2 (1.3%) | 1 (0.7%) | 5 (3.2%) |
| Headache | 30 (19.6%) | 22 (14.7%) | 34 (21.9%) |
| Cough | 1 (0.7%) | 3 (2.0%) | 2 (1.3%) |
| Nasopharyngitis | 5 (3.3%) | 5 (3.3%) | 4 (2.6%) |
| Pharyngitis | 5 (3.3%) | 1 (0.7%) | 0 |
*Intensity given by subjects, the most intense event experienced per subject was considered for classification. No deaths were reported in this study.
†According to MedDRA System Organ Class “gastrointestinal disorders”. Descriptive p values (χ2 test) for between-group differences were p = 0.005 for celecoxib 200 mg once a day vs diclofenac and p = 0.014 for celecoxib 200 mg twice a day vs diclofenac.
§Included were the terms (abdominal pain upper; epigastric discomfort; gastritis NOS; nausea; stomach discomfort) as “upper” GI events and (abdominal distension, abdominal pain NOS, diarrhoea) as “lower” GI events. The four between-group comparisons vs diclofenac were always in favour of celecoxib at either dose (each p<0.05; χ2 test).
‡Incidence of ⩾2% at MedDRA preferred term level in any treatment group, sorted alphabetically.
AE, adverse event; ALAT, alanine aminotransferase;GI, gastrointestinal tract; NOS, not otherwise specified.