Table 8.
Absolute Serum Chemistry Measures in the Modified Intention to Treat Population
| Serum Chemistry Measure | OLIVE | SOYBEAN | OLIVE vs SOYBEAN | ||||
|---|---|---|---|---|---|---|---|
| Visit | N | Mean ± SD | N | Mean ± SD | LS Mean ± SE (95 % CI) | P-value | |
| Alanine aminotransferase, U/L | Baseline | 212 | 41.4 ± 87.15 | 216 | 73.3 ± 197.14 | ||
| Day 5 | 79 | 31.0 ± 27.86 | 85 | 29.2 ± 55.41 | 21.3 ± 6.89 (7.7, 34.9) | 0.002 | |
| EOT/Day 14 | 201 | 48.8 ± 61.23 | 196 | 38.5 ± 38.70 | 42.5 ± 15.24 (12.5, 72.5) | 0.006 | |
| Alkaline phosphatase, U/L | Baseline | 210 | 72.5 ± 46.87 | 212 | 71.7 ± 35.65 | ||
| Day 5 | 79 | 87.7 ± 58.27 | 85 | 74.7 ± 40.41 | 18.8 ± 5.65 (7.7, 30.0) | 0.001 | |
| EOT/Day 14 | 201 | 123 ± 96.24 | 196 | 106.9 ± 70.89 | 11.6 ± 7.72 (−3.6, 26.8) | 0.133 | |
| Aspartate aminotransferase, U/L | Baseline | 210 | 52.8 ± 117.38 | 212 | 72.3 ± 191.38 | ||
| Day 5 | 79 | 31.9 ± 19.27 | 85 | 22.6 ± 15.82 | 22.4 ± 8.87 (4.9, 40.0) | 0.12 | |
| EOT/Day 14 | 201 | 35.8 ± 39.42 | 196 | 30.6 ± 35.13 | 25.5 ± 17.25 (−8.5, 59.4) | 0.141 | |
| γ-Glutamyltransferase, U/L | Baseline | 210 | 39.2 ± 74.63 | 212 | 42.7 ± 70.32 | ||
| Day 5 | 79 | 100.5 ± 136.62 | 85 | 68.9 ± 71.69 | 34.9 ± 11.96 (11.3, 58.5) | 0.004 | |
| EOT/Day 14 | 201 | 139.2 ± 165.89 | 196 | 118.1 ± 140.65 | 12.4 ± 13.45 (−14.1, 38.8) | 0.358 | |
| Total bilirubin, μmol/L | Baseline | 212 | 18.00 ± 15.98 | 216 | 16.12 ± 10.69 | ||
| Day 5 | 79 | 13.21 ± 9.76 | 85 | 11.86 ± 9.56 | −0.39 ± 1.50 (−3.35, 2.56) | 0.793 | |
| EOT/Day 14 | 201 | 12.86 ± 9.34 | 196 | 13.87 ± 18.94 | −2.97 ± 1.42 (−5.76, −0.19) | 0.36 | |
| Blood urea nitrogen, mmol/L | Baseline | 212 | 3.63 ± 2.07 | 216 | 3.88 ± 1.91 | ||
| Day 5 | 85 | 4.21 ± 2.51 | 92 | 4.35 ± 2.71 | 0.51 ± 0.24 (0.03, 0.99) | 0.039 | |
| EOT/Day 14 | 200 | 5.23 ± 2.47 | 195 | 4.93 ± 2.27 | 0.38 ± 0.21 (−0.03, 0.79) | 0.072 | |
| Creatinine, μmol/L | Baseline | 212 | 67.8 ± 23.6 | 218 | 67.4 ± 21.1 | ||
| Day 7 | 110 | 62.0 ± 15.8 | 112 | 60.2 ± 17.4 | −2.3 ± 2.7 (–7.5, 3.0) | 0.40 | |
| EOT/Day 14 | 200 | 62.6 ± 16.5 | 195 | 62.2 ± 16.7 | −0.7 ± 1.7 (-4.1, 2.7) | 0.69 | |
| Chloride, mmol/L | Baseline | 212 | 104.4 ± 4.33 | 216 | 103.7 ± 4.39 | ||
| Day 5 | 85 | 101.4 ± 3.55 | 93 | 102.4 ± 4.53 | −1.6 ± 0.73 (−3.1, −0.2) | 0.027 | |
| EOT/Day 14 | 200 | 101.0 ± 3.55 | 194 | 101.8 ± 5.03 | −1.3 ± 0.59 (−2.5, −0.1) | 0.030 | |
| Phosphorus, mmol/L | Baseline | 155 | 1.07 ± 0.26 | 162 | 1.15 ± 0.79 | ||
| Day 5 | 83 | 1.21 ± 0.47 | 89 | 0.98 ± 0.45 | 0.25 ± 0.09 (0.09, 0.42) | 0.003 | |
| EOT/Day 14 | 183 | 1.26 ± 0.21 | 176 | 1.20 ± 0.32 | 0.17 ± 0.08 (0.00, 0.34) | 0.044 | |
| Potassium, mmol/L | Baseline | 212 | 4.58 ± 9.07 | 216 | 3.98 ± 0.47 | ||
| Day 5 | 85 | 4.35 ± 0.57 | 93 | 3.95 ± 0.53 | 0.43 ± 0.10 (0.23, 0.63) | <0.001 | |
| EOT/Day 14 | 201 | 4.97 ± 9.16 | 194 | 4.06 ± 0.53 | 0.28 ± 0.06 (0.15, 0.40) | <0.001 | |
| Total cholesterol, mmol/L | Baseline | 206 | 3.52 ± 0.95 | 210 | 3.60 ± 0.89 | ||
| Day 5 | 77 | 3.48 ± 0.96 | 84 | 7.60 ± 38.15 | −4.35 (−13.47, 4.77) | 0.348 | |
| EOT/Day 14 | 196 | 3.76 ± 0.90 | 188 | 3.6 ± 0.94 | 0.20 (0.02, 0.39) | 0.029 | |
| Triglycerides, mmol/L | Baseline | 206 | 0.89 ± 0.53 | 211 | 0.91 ± 0.58 | ||
| Day 5 | 77 | 1.89 ± 0.95 | 85 | 1.51 ± 0.68 | 0.41 (0.19, 0.63) | <0.001 | |
| EOT/Day 14 | 200 | 1.72 ± 0.88 | 193 | 1.50 ± 0.67 | 0.25 (0.09, 0.40) | 0.002 | |
Abbreviations: CI confidence interval, EOT end of treatment, LS least squares, SD standard deviation, SE standard error