Table 5: Summary of selected† hematological findings in the 14-day repeated oral toxicity study.

GroupWBCNEULYMMONOEOSRBCHCTMCVMCHMCHCPLTRET
(mg/kg bw/day)×109/L%%%%×1012/LL/LfLpgg/L×109/L%

Male (main groups, = 5 each unless otherwise noted)
Control7.56 ± 1.0314.90 ± 1.9682.56 ± 2.131.78 ± 0.780.74 ± 0.348.17 ± 0.710.44 ± 0.0453.70 ± 2.4719.06 ± 0.78355.20 ± 5.93773.40 ± 66.894.74 ± 0.58
10008.20 ± 1.5415.60 ± 3.1682.20 ± 3.091.66 ± 0.510.46 ± 0.158.59 ± 0.540.45 ± 0.0252.98 ± 2.1219.02 ± 0.74360.20 ± 2.59868.00 ± 47.652.96 ± 0.39∗∗
20007.03 ± 1.409.92 ± 4.6988.90 ± 5.211.06 ± 0.390.12 ± 0.16∗∗8.92 ± 0.720.45 ± 0.0150.62 ± 3.3018.28 ± 0.87361.80 ± 7.60901.80 ± 93.292.51 ± 1.30∗∗
3000††  14.44 ± 2.59∗∗13.35 ± 1.9182.90 ± 2.973.35 ± 1.200.30 ± 0.149.17 ± 0.060.44 ± 0.0248.30 ± 1.8418.40 ± 0.28380.50 ± 9.19∗∗1009.50 ± 44.55∗∗1.49 ± 1.22∗∗
Historical range6.23–13.736.8–28.268.5–91.60.8–3.70.1–2.26.6–9.50.37–0.5048.7–60.817.9–21.1348–377631–11853.35–6.73

Female (main groups, = 5 each unless otherwise noted)
Control6.21 ± 1.1610.46 ± 2.8788.02 ± 3.061.02 ± 0.330.50 ± 0.228.10 ± 0.220.44 ± 0.0154.14 ± 0.9019.40 ± 0.33358.60 ± 3.21913.40 ± 37.324.62 ± 0.82
10007.24 ± 3.2210.36 ± 3.6988.06 ± 4.010.94 ± 0.300.62 ± 0.228.61 ± 0.340.46 ± 0.0152.98 ± 2.5718.90 ± 0.75356.80 ± 5.22887.00 ± 109.733.59 ± 0.53
20007.31 ± 2.7713.26 ± 8.3685.28 ± 8.221.12 ± 0.410.30 ± 0.108.76 ± 0.280.45 ± 0.0151.10 ± 1.0818.38 ± 0.36∗∗359.60 ± 7.16914.60 ± 87.373.44 ± 0.92
3000††  4.13 ± 1.4926.35 ± 20.8672.20 ± 21.781.45 ± 0.920.00 ± 0.00∗∗8.26 ± 0.630.42 ± 0.0250.35 ± 1.2017.95 ± 0.07∗∗357.00 ± 9.901551.00 ± 599.635.58 ± 5.82
Historical range4.07–10.675.5–24.271.7–92.50.7–3.50.2–2.77.8–9.10.41–0.4748.1–57.817.7–20.5353–374635–11182.56–6.97

Data represents the mean values and the standard deviation.
Dose was reduced from 4000 to 3000 mg/kg bw/d on day 2.
: only parameters with statistically significant findings are shown in table.
: dose was reduced from 4000 to 3000 mg/kg bw/d on day 2.
and ∗∗P < 0.01, significance determined with Duncan's multiple range test or with Mann–Whitney test versus control.
: minimum and maximum levels reported as the range of historical control values.