Table 6. Blood parameters where significant changes were observed during treatment for the intent to treat (safety) population.
| Parameter | Time point | CPG–DDS | +artesunate 1 mg/kg | +artesunate 2 mg/kg | +artesunate 4 mg/kg | ||||
| n | Mean±SD | n | Mean±SD | n | Mean±SD | n | Mean±SD | ||
| Adults | |||||||||
| Hemoglobin (g/dL) | Day 0 | 29 | 13.73±2.16 | 30 | 13.49±2.62 | 30 | 12.71±2.41 | 27 | 13.34±2.26 |
| Day 3 | 25 | 12.54±2.95 | 28 | 12.20±2.64 | 25 | 12.22±3.24 | 26 | 12.07±2.22 | |
| Day 7 | 22 | 11.44±2.68 | 27 | 11.61±2.76 | 22 | 11.41±2.49 | 22 | 11.36±2.32 | |
| Day 14a | 11 | 11.32±2.39 | 13 | 10.79±1.44 | 10 | 10.57±1.80 | 8 | 9.58±1.29 | |
| Reticulocyte count (%) | Day 0 | 28 | 1.47±1.78 | 29 | 1.30±1.45 | 29 | 1.45±1.91 | 27 | 1.42±1.47 |
| Day 3 | 25 | 1.29±1.57 | 25 | 1.55±1.82 | 23 | 1.00±1.11 | 25 | 0.85±0.92 | |
| Day 7 | 29 | 1.84±2.80 | 24 | 2.70±4.43 | 21 | 1.84±1.53 | 21 | 2.78±4.35 | |
| Day 14a | 11 | 4.88±3.25 | 12 | 3.12±2.21 | 9 | 2.65±0.69 | 7 | 4.11±0.58 | |
| Methemoglobin (%) | Day 0 | 19 | 0.46±0.45 | 20 | 0.48±0.35 | 22 | 0.38±0.26 | 21 | 0.44±0.37 |
| Day 3 | 16 | 4.75±5.02 | 17 | 2.61±1.82 | 20 | 4.04±4.49 | 19 | 4.76±3.05 | |
| Day 7 | 15 | 1.07±1.34 | 20 | 1.23±0.82 | 16 | 0.95±1.13 | 19 | 0.74±0.37 | |
| Day 14a | 6 | 0.77±0.38 | 9 | 0.57±0.30 | 4 | 0.25±0.25 | 4 | 0.43±0.34 | |
| Platelets (×109/L) | Day 0 | 28 | 106.3±52.9 | 30 | 101.8±50.5 | 30 | 94.6±47.5 | 27 | 109.8±61.5 |
| Day 3 | 25 | 113.2±43.4 | 27 | 163.4±67.2 | 25 | 149.1±42.7 | 26 | 141.3±63.4 | |
| Day 7 | 22 | 176.5±79.6 | 27 | 227.3±79.5 | 22 | 232.4±66.4 | 22 | 232.5±99.9 | |
| Day 14a | 11 | 249.0±105.8 | 12 | 257.2±122.3 | 10 | 253.1±74.0 | 7 | 218.6±84.0 | |
| Children | |||||||||
| Hemoglobin (g/dL) | Day 0 | 24 | 9.03±1.76 | 29 | 9.12±1.48 | 25 | 9.13±1.81 | 27 | 8.89±1.42 |
| Day 3 | 23 | 7.97±2.01 | 27 | 8.54±1.50 | 23 | 8.16±1.66 | 23 | 8.23±1.68 | |
| Day 7 | 23 | 8.48±1.51 | 27 | 8.87±1.35 | 23 | 8.65±1.36 | 23 | 8.52±1.34 | |
| Day 14a | 20 | 9.74±1.29 | 22 | 9.48±1.18 | 18 | 9.71±1.14 | 18 | 9.84±1.35 | |
| Reticulocyte count (%) | Day 0 | 23 | 3.54±2.42 | 28 | 3.32±2.15 | 25 | 3.09±2.29 | 26 | 4.17±3.33 |
| Day 3 | 23 | 2.85±2.25 | 23 | 3.81±3.28 | 21 | 3.44±2.23 | 21 | 2.57±2.94 | |
| Day 7 | 21 | 6.72±4.99 | 24 | 7.12±4.79 | 18 | 6.87±4.90 | 21 | 7.55±7.58 | |
| Day 14a | 20 | 7.97±9.05 | 17 | 4.80±6.30 | 16 | 3.93±3.52 | 14 | 4.74±4.11 | |
| Methemoglobin (%) | Day 0 | 19 | 0.39±0.31 | 25 | 0.43±0.34 | 25 | 0.63±0.58 | 27 | 0.30±0.26 |
| Day 3 | 21 | 2.26±3.21 | 21 | 2.26±2.16 | 21 | 2.49±2.67 | 21 | 2.70±3.43 | |
| Day 7 | 22 | 0.79±1.46 | 26 | 0.40±0.36 | 20 | 0.50±0.40 | 22 | 0.41±0.27 | |
| Day 14a | 13 | 0.38±0.28 | 16 | 0.36±0.39 | 7 | 0.53±0.46 | 11 | 0.39±0.28 | |
| Platelets (×109/L) | Day 0 | 24 | 140.8±68.4 | 28 | 149.3±86.2 | 25 | 126.6±64.0 | 28 | 134.0±86.9 |
| Day 3 | 23 | 167.3±72.6 | 26 | 204.8±107.1 | 21 | 177.5±98.7 | 24 | 157.2±72.8 | |
| Day 7 | 22 | 253.0±133.9 | 26 | 289.8±152.9 | 23 | 282.0±96.1 | 23 | 292.7±109.7 | |
| Day 14a | 20 | 280.6±119.9 | 22 | 354.0±153.5 | 17 | 258.0±119.8 | 18 | 256.9±108.9 | |
a
Day 14 values were obtained only if Day 7 values were abnormal.