Table 2.
Adverse events with an incidence ≥1% in any group
| Placebo n=124 |
Celecoxib n=248 |
Etodolac n=244 |
|
|---|---|---|---|
| All adverse eventsa) | 41(33.1%) | 75(30.2%) | 84(34.4%) |
| Gastrointestinal disorders | 6(4.8%) | 6(2.4%) | 10(4.1%) |
| Constipation | 1(0.8%) | 3(1.2%) | 3(1.2%) |
| Diarrhea | 2(1.6%) | 1(0.4%) | 1(0.4%) |
| Nausea | 1(0.8%) | 0 | 4(1.6%) |
| General disorders and administration site conditions | 6(4.8%) | 2(0.8%) | 3(1.2%) |
| Pyrexia | 4(3.2%) | 2(0.8%) | 3(1.2%) |
| Investigations | 30(24.2%) | 56(22.6%) | 68(27.9%) |
| Alanine aminotransferase increased | 0 | 2(0.8%) | 3(1.2%) |
| Aspartate aminotransferase increased | 1(0.8%) | 2(0.8%) | 3(1.2%) |
| Beta 2 microglobulin urine increased | 5(4.0%) | 11(4.4%) | 16(6.6%) |
| Beta-N-acetyl-D-glucosaminidase increased | 6(4.8%) | 5(2.0%) | 8(3.3%) |
| Blood bilirubin increased | 2(1.6%) | 3(1.2%) | 2(0.8%) |
| Blood creatine phosphokinase increased | 1(0.8%) | 6(2.4%) | 4(1.6%) |
| Glucose urine present | 5(4.0%) | 4(1.6%) | 6(2.5%) |
| Blood urine present | 3(2.4%) | 8(3.2%) | 5(2.0%) |
| Occult blood positive | 21(16.9%) | 31(12.5%) | 39(16.0%) |
| Urobilinogen urine increased | 0 | 3(1.2%) | 2(0.8%) |
| Nervous system disorders | 2(1.6%) | 7(2.8%) | 8(3.3%) |
| Headache | 2(1.6%) | 6(2.4%) | 8(3.3%) |
a) Adverse events (MedDRA/J ver.13.1) with an incidence of 1% or higher in any group are listed for the safety analysis set. Data are shown as the number (%) of patients.