Table 1. Summary of demographics and baseline patient characteristicsa.
| Placebo (N=452) | Plecanatide 3 mg (N=453) | Plecanatide 6 mg (N=441) | |
|---|---|---|---|
| Age (years) | 46.4 | 45.0 | 45.1 |
| Range | (18–78) | (18–79) | (18–79) |
| Gender (% female) | 79.0 | 81.2 | 82.1 |
| Race (% of population) | |||
| White | 71.5 | 66.7 | 68.5 |
| Black | 23.9 | 28.5 | 24.5 |
| Other | 4.6 | 4.8 | 7.0 |
| Body mass index | 28.1±5.3 | 28.1±5.3 | 28.2±5.3 |
| CSBMs/week | 0.4±0.6 | 0.3±0.5 | 0.3±0.5 |
| SBMs/week | 2.2±2.0 | 2.0±1.8 | 1.8±1.8 |
| Stool consistencyb | 2.6±1.1 | 2.5±1.1 | 2.6±1.2 |
| Straining scorec | 2.3±0.8 | 2.3±0.8 | 2.3±0.9 |
| Abdominal discomfort scored | 1.8±0.9 | 1.8±0.8 | 1.8±0.9 |
| Abdominal bloating scoree | 1.9±0.9 | 1.9±0.9 | 1.9±1.0 |
CSBM, complete spontaneous bowel movement; ITT, intention-to-treat; SBM, spontaneous bowel movement.
Values are mean±s.d. in the ITT population unless otherwise stated.
Stool consistency was assessed with the use of the 7-point Bristol Stool Form Scale, where 1 indicates separate, hard lumps, like nuts (hard to pass); 2 sausage-shaped but lumpy; 3 like a sausage but with cracks on the surface; 4 like a sausage or snake, smooth and soft; 5 soft blobs with clear-cut edges (passed easily); 6 fluffy pieces with ragged edges or a mushy stool; and 7 watery, no solid pieces (entirely liquid).
Assessed using the Daily Symptom Diary; patients who indicated having a bowel movement for that day were asked: For today, when you had a bowel movement, rate your straining at its worst on a scale of 0 to 4. Straining was rated on a 5-point Likert scale where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe.
Assessed using the Daily Symptom Diary; patients were asked: For today, rate your abdominal discomfort at its worst on a scale of 0 to 4. Abdominal discomfort was rated on a 5-point Likert scale where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe.
Assessed using the Daily Symptom Diary; patients were asked: For today, rate your abdominal bloating at its worst on a scale of 0 to 4. Abdominal bloating was rated on a 5-point Likert scale where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe.