Table 2 Laboratory test results (safety set)
Variables | DA-5521 (N = 23**) Mean±SD | Placebo (N = 24) Mean±SD | p-value |
|
WBC (103/mL) | 5.66±0.97 | 6.24±1.11 | 0.0621* |
RBC (1003/mL) | 4.81±0.22 | 4.86±0.23 | 0.4588* |
Hemoglobin (g/dL) | 14.98±0.66 | 15.10±0.75 | 0.5720* |
Hematocrit (%) | 44.16±1.97 | 44.55±2.09 | 0.5107* |
MCV (fL) | 91.88±3.41 | 91.74±2.85 | 0.8815& |
Platelet (103/mL) | 248.61±51.98 | 253.46±47.77 | 0.7405* |
Neutrophil (%) | 50.73±7.45 | 51.23±9.21 | 0.4758& |
Lymphocyte (%) | 36.77±6.63 | 34.46±9.22 | 0.6245& |
Monocyte (%) | 8.34±1.77 | 8.26±1.74 | 0.8820* |
Eosinophil (%) | 3.44±2.77 | 3.33±2.96 | 0.7737& |
Basophil (%) | 0.72±0.39 | 0.73±0.35 | 0.8894& |
ALP (IU/L) | 72.43±24.39 | 73.04±23.43 | 0.9311* |
γ-GTP (IU/L) | 28.17±17.17 | 28.83±16.10 | 0.7981& |
AST (GOT) (IU/L) | 22.30±6.57 | 23.46±7.68 | 0.7169& |
ALT (GPT) (IU/L) | 25.57±13.13 | 28.21±14.28 | 0.6316& |
Total bilirubin (mg/dL) | 0.81±0.29 | 0.77±0.21 | 0.7016& |
Protein (g/DL) | 6.83±0.30 | 4.55±0.19 | 0.4700* |
Albumin (d/DL) | 4.54±0.18 | 16.13±2.44 | 0.4510* |
BUN (mg/dL) | 16.3±3.71 | 0.90±0.08 | 0.8301& |
Creatinine (mg/dL) | 0.89±0.08 | 6.31±0.83 | 0.7977* |
Uric acid (mg/dL) | 6.25±0.87 | 9.70±0.28 | 0.7945* |
Glucose (mg/dL) | 85.09±6.81 | 84.63±6.52 | 0.2614* |
Excluding 1 subject who dropped out after visit two (visit two: placebo, visit three: DA-5521)
Comparison between groups: p-value for the two-sample t-test
Comparison between groups: p-value for Wilcoxon rank-sum test
WBC, white blood cell; RBC, red blood cell; MCV, mean corpuscular volume; ALP, alkaline phosphatase; γ-GTP, gamma-glutamic transpeptidase; AST (GOT), aspartate aminotransferase; ALT (GPT), alanine aminotransferase; BUN, blood urea nitrogen