Table 1. Summary of Patient Demographic and Baseline Characteristics (ITT Population).
| Placebo | Linaclotide | ||
|---|---|---|---|
| 145 μg | 290 μg | ||
| (N = 171) | (N = 153) | (N = 159) | |
| Demographic data | |||
| Age (years), mean (range) | 46.4 (18–78) | 48.3 (20–77) | 47.4 (19–80) |
| ≥ 65 years, n (%) | 16 (9.4) | 12 (7.8) | 18 (11.3) |
| Sex, n (%) | |||
| Female | 157 (91.8) | 138 (90.2) | 147 (92.5) |
| Male | 14 (8.2) | 15 (9.8) | 12 (7.5) |
| Race, n (%) | |||
| White | 119 (69.6) | 97 (63.4) | 111 (69.8) |
| Black | 46 (26.9) | 54 (35.3) | 47 (29.6) |
| Other | 6 (3.5) | 2 (1.3) | 1 (0.6) |
| BMI (kg/m2), mean (SD) | 28.4 (6.1) | 29.2 (6.0) | 29.8 (6.6) |
| Baseline data, mean (SD) | |||
| Abdominal bloating a | 7.1 (1.2) | 7.1 (1.3) | 7.1 (1.3) |
| CSBMs/week | 0.2 (0.4) | 0.2 (0.4) | 0.2 (0.4) |
| SBMs/week | 1.8 (1.2) | 1.7 (1.2) | 1.6 (1.4) |
| Days with an SBM (per week) | 1.7 (1.1) | 1.6 (1.1) | 1.5 (1.2) |
| Stool consistency score b | 2.3 (1.1) | 2.4 (1.0) | 2.3 (1.0) |
| Straining score c | 3.6 (0.8) | 3.7 (0.8) | 3.6 (0.9) |
| Constipation severity d | 3.9 (0.6) | 3.9 (0.6) | 3.9 (0.7) |
BMI = body mass index; CSBM = complete spontaneous bowel movement; ITT = intent-to-treat; SBM = spontaneous bowel movement; SD = standard deviation.
a Assessed using an 11-point numerical rating scale (0 to 10; higher score indicates greater severity).
b Assessed using the 7-point BSFS (1 = separate hard lumps like nuts to 7 = watery, no solid pieces).
c Assessed using a 5-point ordinal scale (1 = not at all to 5 = an extreme amount).
d Assessed using a 5-point ordinal scale (1 = none to 5 = very severe).