Table 3 Number of patients with a change in hematology and blood chemistry parameter from normal at baseline to below or above the defined normal range at end of treatment
Parameter (Unit) | Placebo (n = 271) | Active (n = 279) |
|---|---|---|
Hematology | ||
Platelets [1000/μL] | 5 | 2 |
Leukocytes [1000/μL] | 15 | 21 |
Lymphocytes [%] | 32 | 26 |
Basophils [%] | 8 | 13 |
Eosinophils [%] | 26 | 33 |
Monocytes [%] | 17 | 16 |
Neutrophils [%] | 25 | 27 |
Erythrocytes [106/μL] | 17 | 13 |
Haematocrit [%] | 17 | 13 |
Haemoglobin [g/dL] | 15 | 13 |
MCH [pg]1 | 11 | 9 |
MCHC [g/dL]1 | 15 | 15 |
MCV [fL]1 | 9 | 9 |
Blood chemistry | ||
Potassium [mmol/L] | 11 | 13 |
Sodium [mmol/L] | 9 | 7 |
Gamma-GT [U/L]2 | 6 | 3 |
SGOT (AST) [U/L] | 3 | 5 |
SGPT (ALT) [U/L] | 10 | 8 |
Creatinine [mg/dL] | 12 | 9 |
Bilirubin [mg/dL] | 3 | 4 |
Urea [mg/dL] | 4 | 7 |