Variable (Laboratory reference range) | Time | Robenacoxib (n = 118) | Placebo (n = 119) | P value | ||||
---|---|---|---|---|---|---|---|---|
 |  | Mean (±SD) | Casesa | Mean (±SD) | Casesa |  | ||
 |  |  | High | Low |  | High | Low |  |
Serum | ||||||||
 Urea nitrogen, mg/dL (6–31 mg/dL) | Pre-Treatment | 18.1 (±7.3) | 5 | 0 | 18.3 (±6.5) | 5 | 0 | 0.078 |
Study Exit | 14.9 (±4.8) | 1 | 0 | 13.6 (±4.1) | 0 | 0 | ||
 Creatinine, mg/dL (0.5–1.6 mg/dL) | Pre-Treatment | 0.91 (±0.25) | 2 | 1 | 0.96 (±0.28) | 2 | 2 | 0.763 |
Study Exit | 0.79 (±0.21) | 0 | 5 | 0.81 (±0.20) | 0 | 1 | ||
 Alkaline phosphatase, U/L (5–131 U/L) | Pre-Treatment | 141.8 (±239.7) | 26 | 0 | 112.0 (±214.7) | 23 | 0 | 0.233 |
Study Exit | 162.1 (±281.5) | 30 | 0 | 116.4 (±176.3) | 21 | 0 | ||
 Alanine aminotransferase, U/L (12–118 U/L) | Pre-Treatment | 55.3 (±41.6) | 6 | 0 | 54.0 (±50.0) | 7 | 1 | 0.613 |
Study Exit | 53.7 (±49.4) | 5 | 0 | 59.1 (±101.2) | 5 | 1 | ||
 Aspartate aminotransferase, U/L (15–66 U/L) | Pre-Treatment | 29.6 (±10.5) | 1 | 1 | 28.8 (±7.8) | 0 | 1 | 0.449 |
Study Exit | 37.5 (±46.6) | 6 | 1 | 41.7 (±41.3) | 11 | 0 | ||
 Total bilirubin, mg/dL (0.1–0.3 mg/dL) | Pre-Treatment | 0.14 (±0.06) | 1 | 0 | 0.15 (±0.05) | 0 | 0 | 0.431 |
Study Exit | 0.15 (±0.07) | 3 | 0 | 0.15 (±0.07) | 2 | 0 | ||
 Total protein, g/dL (5.0–7.4 g/dL) | Pre-Treatment | 6.6 (±0.54) | 7 | 0 | 6.5 (±0.57) | 7 | 0 | 0.806 |
Study Exit | 6.4 (±0.53) | 4 | 0 | 6.4 (±0.57) | 6 | 0 | ||
 Albumin, g/dL (2.7–4.4 g/dL) | Pre-Treatment | 3.6 (±0.34) | 0 | 1 | 3.6 (±0.34) | 0 | 1 | 0.501 |
Study Exit | 3.5 (±0.32) | 0 | 1 | 3.4 (±0.36) | 0 | 2 | ||
Hematology | ||||||||
 Hemoglobin, g/dL (12.1–20.3 g/dL) | Pre-Treatment | 16.2 (±2.1) | 2 | 3 | 16.4 (±1.8) | 0 | 1 | 0.380 |
Study Exit | 15.1 (±1.8) | 0 | 8 | 15.0 (±1.8) | 0 | 8 | ||
 Hematocrit, % (36–60%) | Pre-Treatment | 49.8 (±6.4) | 5 | 1 | 50.2 (±5.5) | 2 | 0 | 0.302 |
Study Exit | 46.5 (±5.2) | 0 | 5 | 46.2 (±4.9) | 1 | 1 | ||
 Red blood cell count, 1012/L (4.8–9.3 1012/L) | Pre-Treatment | 6.8 (±0.89) | 0 | 0 | 6.9 (±0.76) | 0 | 0 | 0.406 |
Study Exit | 6.3 (±0.78) | 0 | 2 | 6.4 (±0.70) | 0 | 0 | ||
 White blood cell count, 109/L (4.0–15.5 109/L) | Pre-Treatment | 10.9 (±3.7) | 13 | 0 | 10.4 (±3.0) | 6 | 1 | 0.454 |
Study Exit | 13.5 (±4.0) | 32 | 0 | 13.6 (±4.4) | 37 | 0 | ||
Urine | ||||||||
 Urine specific gravity (1.015–1.050) | Pre-Treatment | 1.03 (±0.02) | 23 | 8 | 1.03 (±0.01) | 13 | 15 | 0.839 |
Study Exit | 1.04 (±0.02) | 27 | 5 | 1.04 (±0.02) | 25 | 5 |