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. 2014 Jun 7;74(2):267–275. doi: 10.1007/s00280-014-2484-y

Table 3.

Adjusted gMean ratios for AUC and C max of afatinib 50 mg (subjects with hepatic impairment versus controls), % with 90 % CI

Parameter and unit Hepatic impairment group gMean ratio (%) (90 % CI)a Intraindividual gCV (%)b
AUC0–∞ (ng h/mL) Mild 92.6 (68.0–126.3) 33.6
Moderate 94.9 (72.3–124.5) 31.6
C max (ng/mL) Mild 109.5 (82.7–144.9) 30.3
Moderate 126.9 (86.0–187.2) 42.8
AUC0–tz (ng h/mL) Mild 90.6 (66.9–122.7) 32.8
Moderate 94.5 (71.6–124.8) 32.4

AUC 0tz area under the drug plasma concentration–time curve from time 0 to the time of the last quantifiable data point, AUC 0 area under the drug plasma concentration–time curve from time 0 to infinity, C max maximum drug concentration in plasma, gCV geometric coefficient of variation (%), gMean geometric mean

aRatio of gMeans (hepatic impairment subjects to healthy subjects). Statistical assessment of differences in pharmacokinetic parameters between patients with mild and moderate hepatic impairment and healthy subjects was performed using separate ANOVA models

bSee Table 2 for the individual group means for each treatment group