Table 1.
Baseline Demographics and Disease Characteristics of Asian and Non-Asian Women (Intent-to-Treat Analysis Set)
| Variables | Asian (n = 424) | Non-Asian (n = 1,172) | Total (N = 1,596) |
|---|---|---|---|
| Age (mean [SD], yr) | 41.0 (12.92) | 45.2 (13.63) | 44.1 (13.57) |
| Baseline BMI (mean [SD], kg/m2) | 22.1 (3.07) | 25.2 (5.06)a | 24.3 (4.81)b |
| Average BMs/wk (mean [SD]) | 2.2 (0.98) | 5.3 (3.65)c | 4.5 (3.46)d |
| Average SBMs/wk (n [%]) | |||
| < 1 | 191 (45.0) | 334 (28.6)c | 525 (33.0)d |
| 1–2 | 213 (50.2) | 203 (17.4)c | 416 (26.1)d |
| > 2e | 20 (4.7) | 632 (54.1)c | 652 (40.9)d |
| Mean (SD) | 1.1 (0.84) | 3.4 (3.79)c | 2.8 (3.43)d |
| Average SCBMs/wk (mean [SD]) | 0.3 (0.45) | 0.4 (0.68)c | 0.4 (0.63)d |
| Average bisacodyl/wk (n [%]) | |||
| 0 | 121 (28.5) | 363 (31.1)c | 484 (30.4)d |
| < 2 | 161 (38.0) | 322 (27.5)c | 483 (30.3)d |
| ≥ 2 | 142 (33.5) | 484 (41.4)c | 626 (39.3)d |
| Mean (SD) | 1.6 (1.73) | 2.1 (2.46)c | 1.9 (2.30)d |
| Average enema/wk (mean [SD]) | 0.1 (0.30) | 0.1 (0.34)c | 0.1 (0.33)d |
| Average number of days with bisacodyl/wk (mean [SD]) | 0.9 (0.82) | 0.9 (0.91) | 0.9 (0.89) |
| Average number of days with bisacodyl or enema/wk (mean [SD]) | 1.0 (0.87) | 0.9 (0.94) | 0.9 (0.92) |
a
n = 1,170;
b
N = 1,594;
c
n = 1,169;
d
N = 1,593;
e
Based on patients’ diary data before the day of first dose, and the numbers of spontaneous bowel movements (SBMs)/week at baseline could be different from the investigator’s calculation at randomization in Asia-Pacific study.
n, sub-group population; N, total population; SD, standard deviation; yr, year; BMI, body mass index; BM, bowel movement; wk, week; SCBM, spontaneous complete bowel movement.