Table 2.
Demographic and baseline characteristics of subjects
| Characteristic/statistic | Dose escalation | Mass balance | Food effect | Hepatic impairment | Phase III | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Fasted | Fed | Mildly impaired | Matched control | Moderately impaired | Matched control | Active | Placebo | |||
| Male sex [n (%)] | 140 (100) | 6 (100) | 30 (100) | 30 (100) | 8 (100) | 8 (100) | 8 (100) | 9 (100) | 800 (100) | 399 (100) |
| Race [n (%)] | ||||||||||
| White | 135 (96) | 5 (83) | 25 (83) | 23 (77) | 8 (100) | 8 (100) | 8 (100) | 9 (100) | 745 (93) | 366 (92) |
| Other | 5 (4) | 1 (17) | 5 (17) | 7 (23) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 55 (7) | 33 (8) |
| Ethnicity [n (%)] | ||||||||||
| NHL | 134 (96) | 6 (100) | 18 (60) | 24 (80) | 8 (100) | 8 (100) | 8 (100) | 9 (100) | 768 (96) | 376 (94) |
| HL | 5 (4) | 0 (0) | 12 (40) | 6 (20) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 325 (4) | 23 (6) |
| Age, years | ||||||||||
| Median | 68 | 24 | 28 | 31 | 39 | 43 | 52 | 54 | 69 | 69 |
| Range | 44–93 | 21–38 | 19–42 | 19–55 | 24–63 | 26–59 | 36–67 | 37–63 | 41–92 | 49–89 |
| Actual body weight, kg [mean (SD)] | 93.9 (17.2) | 75.5 (10.6) | 79.0 (12.7) | 78.7 (7.4) | 87.2 (19.5) | 87.4 (10.0) | 88.8 (15.6) | 90.8 (9.5) | 84.2 (14.5) | 85.0 (16.6) |
| BMI, kg/m2 [mean (SD)] | ND | 23.3 (2.3) | 25.6 (3.1) | 25.2 (2.4) | 28.5 (4.5) | 27.1 (2.8) | 27.8 (3.5) | 27.6 (2.3) | ND | ND |
BMI body mass index, HL Hispanic or Latino, ND not determined, NHL not Hispanic or Latino, SD standard deviation