Table 1.
Baseline characteristics of the trial population (modified intent-to-treat population)
| Naldemedine |
||||
|---|---|---|---|---|
| Placebo(N = 61) | 0.1 mg/day(N = 61) | 0.2 mg/day(N = 59) | 0.4 mg/day(N = 57) | |
| Age, y | 53.1 (10.9) | 49.5 (9.7) | 50.7 (11.4) | 54.1 (11.2) |
| Female, N (%) | 45.0 (73.8) | 47.0 (77.0) | 38.0 (64.4) | 37.0 (64.9) |
| Race, N (%) | ||||
| White | 49 (80.3) | 49 (80.3) | 47 (79.7) | 51 (89.5) |
| Black | 9 (14.8) | 11 (18.0) | 12 (20.3) | 6 (10.5) |
| Other | 3 (4.9) | 1 (1.6) | 0 | 0 |
| Ethnicity, N (%) | ||||
| Hispanic or Latino | 4 (6.6) | 6 (9.8) | 2 (3.4) | 4 (7.0) |
| Not Hispanic or Latino | 57 (93.4) | 55 (90.2) | 57 (96.6) | 53 (93.0) |
| Body mass index, kg/m2 | 29.8 (7.2) | 29.6 (6.3) | 32.0 (8.1) | 30.6 (5.6) |
| No. of SBMs/wk | 1.22 (0.72) | 1.51 (0.82) | 1.52 (0.92) | 1.20 (0.95) |
| No. of CSBMs/wk | 0.38 (0.53) | 0.49 (0.70) | 0.52 (0.70) | 0.39 (0.67) |
| Equivalent daily morphine dose, mg/day | 146.5 (212.5) | 120.6 (206.7) | 124.3 (158.6) | 125.3 (143.2) |
All data are mean (standard deviation) unless otherwise stated.
CSBM = complete spontaneous bowel movement; SBM = spontaneous bowel movement.