Table 3.
gMean ratios (%) for AUC and C max of afatinib 40 mg (subjects with renal impairment versus controls), with 90 % confidence intervals (CIs) in each renal impairment group based on estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease formula [15]
| Parameter | Renal impairment group | gMean ratio % (90 % CI)a | Inter-individual gCV [%]b | P value |
|---|---|---|---|---|
| AUClast | Moderate | 122.2 (95.7–156.0) | 28.3 | 0.17 |
| Severe | 150.0 (105.3–213.7) | 41.9 | 0.06c | |
| C max | Moderate | 101.2 (72.9–140.3) | 38.5 | 0.95 |
| Severe | 121.7 (90.8–163.2) | 34.2 | 0.26 | |
| AUC∞ | Moderate | 122.4 (96.1–155.9) | 28.0 | 0.16 |
| Severe | 150.1 (105.6–213.3) | 41.5 | 0.06c |
AUC last area under the drug plasma concentration–time curve from time 0 to the time of the last quantifiable data point, AUC ∞ area under the drug plasma concentration–time curve from time 0 to infinity, CI confidence interval, C max maximum drug concentration in plasma, gCV geometric coefficient of variation (%), gMean geometric mean
aRatio of gMeans (renal impairment subjects to healthy subjects). Statistical assessment of differences in pharmacokinetic parameters between subjects with moderate and severe renal impairment and healthy subjects was performed using separate ANOVA models
bSee Table 2 for the individual group means for each treatment group
cTwo-sided P values <0.1 indicate formal significance