Table 1.
Demographics and baseline characteristics (safety analysis set)
| Study 11 (n = 18) | Study 22 (n = 18) | Study 33 (n = 8) | |
|---|---|---|---|
| Sex, n | |||
| Women | – | 8 | 5 |
| Men | 18 | 10 | 3 |
| Race, n (%) | |||
| White | 4 (22) | 5 (28) | 8 (100) |
| Black or African American | 11 (61) | 11 (61) | – |
| Other/multiple | 2 (11) | 2 (11) | – |
| Ethnicity, n (%) | |||
| Not Hispanic or Latino | 16 (89) | 16 (89) | 8 (100) |
| Hispanic or Latino | 2 (11) | 2 (11) | 0 |
| Age (years) | |||
| Mean (SD) | 33.7 (8.8) | 41.1 (11.6) | 46.4 (8.1) |
| Baseline weight (kg) | |||
| Mean (SD) | 78.0 (7.4) | 77.6 (8.7) | 70.0 (13.2) |
| Baseline BMI (kg/m2) | |||
| Mean (SD) | 26.1 (2.3) | 26.4 (2.5) | 23.5 (2.7) |
BMI, body mass index; GFJ, grapefruit juice; SD, standard deviation.
1
Study 1: ibrutinib + ketoconazole.
2
Study 2: ibrutinib + rifampin.
3
Study 3: Ibrutinib + grapefruit juice.