Parameter | PFS | AI | Adjusted gMean ratio (AI/PFS)* | 2-sided 90% CI* | ||
---|---|---|---|---|---|---|
n | Adjusted gMean* | n | Adjusted gMean* | |||
AUC0–∞† [μg·h/mL] | 35‡ | 2270 | 35 | 2280 | 100.22 | 82.13, 122.29 |
AUC0–1032 [μg·h/mL] | 35‡ | 1960 | 35 | 1960 | 100.14 | 85.15, 117.76 |
Cmax [μg/mL] | 36 | 3.76 | 35 | 4.14 | 110.19 | 96.80, 125.44 |
*Adjusted for treatment and BMI group as fixed effects; †Based on observed last concentration values; ‡AUC values could not be calculated for one subject (Subject 1001-0110), due to the lack of appropriate terminal phase (only one non-BLQ [below the limit of quantification] value in the elimination phase).