TABLE 1.
Patients’ demographic and baseline∗ characteristics
| Treatment group | |||
| Category | Lubiprostone 12 mcg BID (n = 56) | Lubiprostone 24 mcg BID (n = 31) | Total lubiprostone (N = 87) |
| Sex, no. (%) | |||
| Female | 32 (57.1) | 17 (54.8) | 49 (56.3) |
| Male | 24 (42.9) | 14 (45.2) | 38 (43.7) |
| Age, y | |||
| Mean (SD) | 8.8 (1.81) | 13.2 (2.65) | 10.3 (3.03) |
| Age group, no. (%) | |||
| 6–9 y | 39 (69.6) | 3 (9.7) | 42 (48.3) |
| 10–13 y | 16 (28.6) | 14 (45.2) | 30 (34.5) |
| 14–17 y | 1 (1.8) | 14 (45.2) | 15 (17.2) |
| Race, no. (%) | |||
| White | 43 (76.8) | 25 (80.6) | 68 (78.2) |
| Black or African American | 11 (19.6) | 5 (16.1) | 16 (18.4) |
| Other | 2 (3.6) | 1 (3.2) | 3 (3.4) |
| American Indian or Alaska Native | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Ethnicity, no. (%) | |||
| Not Hispanic or Latino | 50 (89.3) | 27 (87.1) | 77 (88.5) |
| Hispanic or Latino | 6 (10.7) | 4 (12.9) | 10 (11.5) |
| Height, cm | |||
| Mean (SD) | 135.8 (10.53) | 159.9 (11.17) | 144.4 (15.78) |
| Weight, kg | |||
| Mean (SD) | 33.0 (7.75) | 66.4 (17.82) | 44.9 (20.19) |
| Body weight group, no. (%) | |||
| <50 kg | 56 (100.0) | 0 (0.0) | 56 (64.4) |
| ≥50 kg | 0 (0.0) | 31 (100.0) | 31 (35.6) |
| BMI, kg/m2 | |||
| Mean (SD) | 17.7 (2.43) | 26.0 (6.42) | 20.7 (5.85) |
BID = twice daily; BMI = body mass index; n = subgroup of total population; N = total population; SD = standard deviation.
∗
Baseline was defined as the last non-missing measurement recorded before the date and time of the first dose of study medication.