Table 4 Laboratory parameters in the safety population
Parameter | Statistic | Screening | Week 1 | Week 2 |
|---|---|---|---|---|
Patient number (Safety Population) | N | 11 | 11 | 10 |
Erythrocytes (10^12/L) | Mean (SD) | 4.0 (0.58) | 3.6 (0.52) | 3.4 (0.57) |
Median | 4.1 | 3.7 | 3.6 | |
Min, Max | 2.8, 4.7 | 2.9, 4.3 | 2.4, 4.0 | |
Leukocytes (10^9/L) | Mean (SD) | 8.3 (5.45) | 7.1 (2.70) | 5.8 (1.94) |
Median | 6.9 | 6.4 | 5.6 | |
Min, Max | 3.1, 23.9 | 3.7, 13.4 | 2.6, 8.5 | |
Hematocrit (%) | Mean (SD) | 37.5 (4.57) | 34.1 (3.79) | 31.7 (4.14) |
Median | 37.9 | 34.3 | 31.8 | |
Min, Max | 28.9, 43.2 | 28.9, 40.5 | 23.8, 36.4 | |
Hemoglobin (g/dL) | Mean (SD) | 11.8 (1.56) | 10.9 (1.27) | 10.1 (1.38) |
Median | 12 | 10.8 | 10 | |
Min, Max | 9.0, 13.8 | 9.3, 12.7 | 7.6, 11.8 | |
MCH (pg/cell) | Mean (SD) | 30.1 (2.42) | 30.2 (2.35) | 29.8 (2.62) |
Median | 30.8 | 30.7 | 30.1 | |
Min, Max | 23.8, 32.5 | 24.1, 33.1 | 23.5, 32.5 | |
MCHC (g/dL) | Mean (SD) | 31.6 (0.98) | 32.0 (0.97) | 31.8 (1.24) |
Median | 31.7 | 32.1 | 31.8 | |
Min, Max | 29.6, 33.4 | 29.7, 33.2 | 29.1, 33.3 | |
MCV (fL) | Mean (SD) | 95.2 (6.15) | 94.2 (5.94) | 93.7 (6.03) |
Median | 95.4 | 94.3 | 93.5 | |
Min, Max | 80.6, 104.3 | 80.9, 102.1 | 80.6, 101.3 | |
RDW (%) | Mean (SD) | 14.8 (1.36) | 14.8 (1.44) | 14.3 (1.09) |
Median | 14.5 | 14.3 | 14 | |
Min, Max | 12.7, 18.0 | 13.0, 17.9 | 13.3, 16.5 | |
Platelets (10^9/L) | Mean (SD) | 251.6 (117.6) | 220.8 (85.90) | 205.8 (97.71) |
Median | 227 | 192 | 171 | |
Min, Max | 159.0, 501.0 | 143.0, 396.0 | 101.0, 450.0 | |
MPV (fL) | Mean (SD) | 10.6 (0.84) | 10.9 (1.01) | 11.0 (0.94) |
Median | 10.4 | 10.5 | 11.1 | |
Min, Max | 9.5, 12.2 | 9.1, 12.4 | 9.3, 12.4 | |
Absolute Basophils (10^9/L) | Mean (SD) | 0.0 (0.04) | 0.0 (0.04) | 0.0 (0.03) |
Median | 0 | 0 | 0 | |
Min, Max | 0.0, 0.1 | 0.0, 0.1 | 0.0, 0.1 | |
Absolute Eosinophils (10^9/L) | Mean (SD) | 0.2 (0.13) | 0.2 (0.11) | 0.2 (0.11) |
Median | 0.1 | 0.2 | 0.1 | |
Min, Max | 0.1, 0.4 | 0.1, 0.4 | 0.1, 0.4 | |
Absolute Lymphocytes (10^9/L) | Mean (SD) | 2.0 (1.03) | 1.7 (0.53) | 1.6 (0.73) |
Median | 1.7 | 1.7 | 1.6 | |
Min, Max | 0.7, 4.3 | 0.9, 2.5 | 0.6, 2.9 | |
Absolute Monocytes (10^9/L) | Mean (SD) | 0.6 (0.38) | 0.7 (0.34) | 0.5 (0.18) |
Median | 0.5 | 0.6 | 0.5 | |
Min, Max | 0.3, 1.7 | 0.3, 1.5 | 0.2, 0.8 | |
Absolute Neutrophils (10^9/L) | Mean (SD) | 5.4 (4.30) | 4.5 (2.45) | 3.5 (1.31) |
Median | 4.4 | 3.8 | 3.6 | |
Min, Max | 2.0, 17.7 | 2.1, 10.5 | 1.7, 5.7 | |
Percent Basophils (%) | Mean (SD) | 0.4 (0.24) | 0.6 (0.35) | 0.6 (0.40) |
Median | 0.3 | 0.6 | 0.5 | |
Min, Max | 0.2, 1.0 | 0.1, 1.3 | 0.1, 1.5 | |
Percent Eosinophils (%) | Mean (SD) | 2.5 (1.78) | 2.9 (1.35) | 2.8 (1.23) |
Median | 1.9 | 2.9 | 2.2 | |
Min, Max | 0.5, 5.7 | 1.3, 4.9 | 1.7, 5.3 | |
Percent Lymphocytes (%) | Mean (SD) | 25.6 (9.02) | 25.2 (7.76) | 27.6 (7.32) |
Median | 24.9 | 24.9 | 27.8 | |
Min, Max | 11.7, 39.5 | 12.3, 36.1 | 15.8, 38.1 | |
Percent Monocytes (%) | Mean (SD) | 8.0 (2.47) | 10.2 (5.97) | 9.5 (3.26) |
Median | 7 | 8.1 | 8.8 | |
Min, Max | 5.9, 13.8 | 4.6, 24.8 | 5.2, 17.0 | |
Percent Neutrophils (%) | Mean (SD) | 63.4 (11.25) | 61.1 (8.92) | 59.6 (7.16) |
Median | 64.5 | 56.9 | 61.5 | |
Min, Max | 44.6, 78.9 | 51.2, 78.5 | 44.6, 67.1 | |
Sodium (mmol/L) | Mean (SD) | 141.1 (3.11) | 141.0 (2.65) | 141.1 (2.39) |
Median | 141 | 141 | 141 | |
Min, Max | 136.0, 149.0 | 138.0, 147.0 | 137.0, 144.0 | |
Potassium (mmol/L) | Mean (SD) | 4.8 (0.50) | 4.8 (0.35) | 4.5 (0.44) |
Median | 4.9 | 4.8 | 4.4 | |
Min, Max | 3.8, 5.5 | 4.1, 5.4 | 3.8, 5.2 | |
Chloride (mmol/L) | Mean (SD) | 96.2 (4.79) | 98.4 (4.30) | 97.5 (5.26) |
Median | 96 | 97 | 99 | |
Min, Max | 88.0, 102.0 | 93.0, 106.0 | 89.0, 106.0 | |
BUN (mg/dL) | Mean (SD) | 36.7 (16.33) | 45.8 (15.06) | 41.3 (17.87) |
Median | 33 | 46 | 36 | |
Min, Max | 16.0, 69.0 | 27.0, 83.0 | 20.0, 82.0 | |
Creatinine (mg/dL) | Mean (SD) | 7.0 (1.46) | 8.1 (1.25) | 7.9 (1.06) |
Median | 6.5 | 7.9 | 8.3 | |
Min, Max | 4.6, 9.5 | 6.4, 10.8 | 6.4, 9.4 | |
BUN/Creatinine (RATIO) | Mean (SD) | 5.2 (1.89) | 5.7 (2.00) | 5.0 (2.36) |
Median | 5 | 5 | 4.5 | |
Min, Max | 2.0, 9.0 | 3.0, 10.0 | 2.0, 10.0 | |
Glucose (mg/dL) | Mean (SD) | 125.1 (56.33) | 139.3 (50.78) | 151.9 (56.93) |
Median | 89 | 118 | 130.5 | |
Min, Max | 78.0, 223.0 | 84.0, 221.0 | 97.0, 237.0 | |
Calcium (mg/dL) | Mean (SD) | 9.3 (0.65) | 8.9 (0.50) | 8.7 (0.57) |
Median | 9.3 | 9 | 8.8 | |
Min, Max | 8.3, 10.8 | 8.0, 9.8 | 7.9, 9.5 | |
Protein (g/dL) | Mean (SD) | 7.4 (0.42) | 6.7 (0.50) | 6.5 (0.42) |
Median | 7.4 | 6.8 | 6.5 | |
Min, Max | 6.6, 8.1 | 6.0, 7.8 | 5.9, 7.5 | |
Globulin (g/dL) | Mean (SD) | 3.0 (0.34) | 2.7 (0.26) | 2.6 (0.25) |
Median | 2.9 | 2.8 | 2.6 | |
Min, Max | 2.3, 3.5 | 2.4, 3.2 | 2.3, 3.2 | |
Albumin (g/dL) | Mean (SD) | 4.4 (0.32) | 4.0 (0.33) | 3.9 (0.28) |
Median | 4.3 | 4.1 | 3.9 | |
Min, Max | 3.8, 4.9 | 3.4, 4.6 | 3.4, 4.3 | |
A/G Ratio (RATIO) | Mean (SD) | 1.5 (0.23) | 1.5 (0.14) | 1.5 (0.14) |
Median | 1.4 | 1.5 | 1.5 | |
Min, Max | 1.2, 2.0 | 1.2, 1.6 | 1.3, 1.7 | |
Albumin/Total Protein (RATIO) | Mean (SD) | 0.6 (0.06) | 0.6 (0.00) | 0.6 (0.00) |
Median | 0.6 | 0.6 | 0.6 | |
Min, Max | 0.5, 0.7 | 0.6, 0.6 | 0.6, 0.6 | |
ALP (ukat/L) | Mean (SD) | 95.4 (37.60) | 88.5 (35.42) | 79.2 (32.93) |
Median | 94 | 83 | 79 | |
Min, Max | 42.0, 160.0 | 40.0, 146.0 | 39.0, 139.0 | |
ALT (ukat/L) | Mean (SD) | 15.1 (5.32) | 15.4 (9.25) | 11.6 (5.06) |
Median | 13 | 12 | 10.5 | |
Min, Max | 9.0, 26.0 | 6.0, 32.0 | 6.0, 22.0 | |
AST (ukat/L) | Mean (SD) | 15.8 (6.15) | 15.9 (8.23) | 15.8 (5.17) |
Median | 14 | 15 | 17 | |
Min, Max | 8.0, 25.0 | 5.0, 30.0 | 9.0, 23.0 | |
Bilirubin (umol/L) | Mean (SD) | 0.4 (0.18) | 0.3 (0.10) | 0.3 (0.12) |
Median | 0.4 | 0.3 | 0.3 | |
Min, Max | 0.2, 0.7 | 0.2, 0.5 | 0.2, 0.6 | |
spKt/V | Mean (SD) | NA | 1.9 (0.38) | 1.9 (0.36) |
Median | NA | 1.9 | 1.8 | |
Min, Max | NA | 1.4, 2.6 | 1.4, 2.4 |