Table 4.
Summary of treatment-emergent adverse events (AEs) in patients with osteoarthritis of the knee who were treated with either 200 mg celecoxib once daily, 800 mg ibuprofen three times daily or placebo for 6 weeks.
| Celecoxib 200 mg once daily n = 153 | Ibuprofen 800 mg three times daily n = 156 | Placebo n = 79 | |
|---|---|---|---|
| Number of AEs | 43 | 66 | 27 |
| Patients with AEs, n (%) | 31 (20.3) | 48 (30.8) | 21 (26.6) |
| Patients with serious AEs, n (%) | 0 | 1 (0.6) | 0 |
| Patients with severe AEs, n (%) | 1 (0.7) | 5 (3.2) | 3 (3.8) |
| Patients discontinued due to AEs, n (%) | 5 (3.3) | 10 (6.4) | 5 (6.3) |
| Patients with dose reduced or temporary discontinuation due AEs, n (%) | 0 | 5 (3.2) | 1 (1.3) |
| UGI eventa | 2 (1.3) | 8 (5.1) | 2 (2.5) |
| Common treatment-related AEs,b n (%) | |||
| Diarrhoea | 4 (2.6) | 1 (0.6) | 1 (1.3) |
| Dyspepsia | 4 (2.6) | 7 (4.5) | 2 (2.5) |
| Abdominal pain | 1 (0.7) | 8 (5.1) | 1 (1.3) |
| Headache | 0 | 1 (0.6) | 2 (2.5) |
Data presented as n of patients (%), which are based on the number of patients evaluable for AEs.
a
Defined as a moderate or severe instance of one or more of abdominal pain, dyspepsia, and/or nausea. There were no statistically significant between-group differences in the number of UGI events with each treatment (P ≥ 0.05).
b
Reported by ≥2% of patients in any treatment group.
UGI, upper gastrointestinal.