Demographic and other baseline characteristics: intention-to-treat population
| Characteristic | Placebo (n=63) | Vedolizumab (n=64) | Total (N=127) |
|---|---|---|---|
| Sex, n (%) | |||
| Male | 43 (68) | 44 (69) | 87 (69) |
| Female | 20 (32) | 20 (31) | 40 (31) |
| Race, n (%) | |||
| White | 56 (89) | 62 (97) | 118 (93) |
| Black | 1 (2) | 1 (2) | 2 (2) |
| Asian | 2 (3) | 1 (2) | 3 (2) |
| Other | 4 (6) | 0 | 4 (3) |
| Age, years | |||
| Mean (SD) | 27.3 (5.33) | 27.7 (5.64) | 27.5 (5.47) |
| Median (range) | 26.0 (19–38) | 28.5 (19–39) | 27.0 (19–39) |
| Weight, kg | |||
| Mean (SD) | 76.2 (11.53) | 75.0 (13.48) | 75.6 (12.51) |
| Median (range) | 75.4 (54.5–112.5) | 73.9 (47.9–107.2) | 74.5 (47.9–112.5) |
| BMI, kg/m2 | |||
| Mean (SD) | 25.4 (2.71) | 24.8 (3.34) | 25.1 (3.04) |
| Median (range) | 25.0 (20.0–31.8) | 24.6 (18.5–31.9) | 24.8 (18.5–31.9) |
The intention-to-treat population was defined as all participants who received any amount of study drug (vedolizumab or placebo) based on their randomised study drug assignment.
BMI, body mass index.