Table 3.
Adverse events (all-causality) in Asian and non-Asian trial populations
| Asiana | Non-Asianb | |||
|---|---|---|---|---|
| Celecoxib | Placebo | Celecoxib | Placebo | |
| n | 145 | 76 | 147 | 65 |
| Number of AEs | 64 | 33 | 81 | 44 |
| Patients with AEs, n (%) | 40 (27.6) | 22 (28.9) | 49 (33.3) | 26 (40.0) |
| Patients with serious AEs, n (%) | 0 | 0 | 1 (0.7) | 0 |
| Patients discontinued due to AEs, n (%) | 10 (6.9) | 3 (3.9) | 5 (3.4) | 5 (7.7) |
| GI-related AEs, n (%) | ||||
| Abdominal pain | 11 (7.6) | 3 (3.9) | 4 (2.7) | 3 (4.6) |
| Dyspepsia | 2 (1.4) | 0 | 4 (2.7) | 1 (1.5) |
| Constipation | 0 | 0 | 1 (0.7) | 1 (1.5) |
| Diarrhea | 2 (1.4) | 0 | 1 (0.7) | 0 |
| Nausea | 1 (0.7) | 1 (1.3) | 6 (4.1) | 0 |
| CNS-related AEs, n (%) | ||||
| Depression | 11 (7.6) | 11 (14.5) | 12 (8.2) | 9 (13.8) |
| Dizziness | 0 | 1 (1.3) | 0 | 1 (1.5) |
| Headache | 3 (2.1) | 0 | 6 (4.1) | 3 (4.6) |
AE adverse event, CNS central nervous system, GI gastrointestinal
aStudy A3191052 conducted in Asian patients
bStudy A3191063, excluding Asian patients