Table 2.
Patient demographics and baseline disease characteristics (treated population)
| Parameter | Normal hepatic function cohort (n = 8) | Mild hepatic impairment cohort (n = 10) | Moderate hepatic impairment cohort (n = 6) |
|---|---|---|---|
| Age, median (range), y | 64.0 (47–77) | 48.5 (37–65) | 62.0 (56–70) |
| Male | 4 (50.0) | 5 (50.0) | 4 (66.7) |
| Race, n (%) | |||
| Asian | 1 (12.5) | 1 (10.0) | 0 |
| Black or African American | 2 (25.0) | 0 | 0 |
| White | 5 (62.5) | 9 (90.0) | 6 (100) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 0 | 0 | 1 (16.7) |
| Not Hispanic or Latino | 8 (100) | 10 (100) | 5 (83.3) |
| Height, mean (SD), cm | 165.80 (10.75) | 168.15 (7.76) | 167.87 (9.57) |
| Weight, mean (SD), kg | 73.20 (27.51) | 75.49 (17.79) | 76.63 (14.64) |
| Body surface area, mean (SD), m2 | 1.79 (0.34) | 1.85 (0.22) | 1.88 (0.21) |
| Bilirubin, mean (SD), μM | 8.55 (3.17) | 13.51 (6.42) | 45.32 (12.65) |
| Aspartate aminotransferase, mean (SD), U/L | 25.63 (7.96) | 55.60 (15.24) | 64.17 (24.21) |
| Number of prior regimens meana (range) | 3.4 (1–7) | 3.5 (1–7) | 3.3 (0–7) |
a
All prior regimens in neoadjuvant, adjuvant and metastatic settings.
SD, standard deviation.