Geometric mean | |||||
---|---|---|---|---|---|
Parameter | Impaired | Normal renal function | Comparison (Group names) | Ratio of means (impaired: normal function) | 90% confidence interval |
AUC(0,∞) (ng ml−1 mg−1 m−2); per unit of dose)* | |||||
Topotecan lactone | 6.33 | 5.90 | B: A | 1.07 | (0.70−1.64) |
Total topotecan | 24.30 | 21.55 | B: A | 1.13 | (0.78−1.64) |
Topotecan lactone | 8.03 | 5.90 | C: A | 1.36 | (0.92−2.02) |
Total topotecan | 34.77 | 21.55 | C: A | 1.61 | (1.14−2.28) |
Topotecan lactone | 12.33 | 5.90 | D: A | 2.09 | (1.38−3.16) |
Total topotecan | 53.37 | 21.55 | D: A | 2.48 | (1.72−3.56) |
Topotecan lactone | 16.13 | 5.90 | E: A | 2.74 | (1.72−4.36) |
Total topotecan | 85.86 | 21.55 | E: A | 3.98 | (2.64−6.01) |
Cmax (ng ml−1 mg−1 m−2; per unit of dose)* | |||||
Topotecan lactone | 1.56 | 1.59 | B: A | 0.98 | (0.63−1.53) |
Total topotecan | 3.54 | 2.99 | B: A | 1.18 | (0.82−1.70) |
Topotecan lactone | 1.91 | 1.59 | C: A | 1.20 | (0.79−1.81) |
Total topotecan | 4.83 | 2.99 | C: A | 1.61 | (1.15−2.26) |
Topotecan lactone | 2.23 | 1.59 | D: A | 1.41 | (0.91−2.17) |
Total topotecan | 5.34 | 2.99 | D: A | 1.79 | (1.25−2.55) |
Topotecan lactone | 2.46 | 1.59 | E: A | 1.55 | (0.95−2.53) |
Total topotecan | 7.06 | 2.99 | E: A | 2.36 | (1.58−3.53) |
Doses are normalized to 1 mg m−2 day−1. Abbreviations: AUC(0,∞), Area under the concentration-time curve from zero (pre-dose) extrapolated to infinity; Cmax, maximum observed plasma concentration.