Table 1 Secondary outcome measures
No. | Outcome measure | Time frame | Statistics |
|---|---|---|---|
1 | Proportion of patients having ≥3 SCBMs/week | Week 1–2, week 9–12, week 9–16, week 9–20, week 9-32 | CMH test |
2 | Proportion of patients with one or more increase in SCBMs/week from baseline | Week 1–2, week 3–8, week 9–12, week 9–16, week 9–20, week 9-32 | CMH test |
3 | SCBMs/week and change from baseline | Week 1–2, week 3–8, week 9–12, week 9–16, week 9–20, week 9-32 | Nonparametric test |
4 | SBMs/week and change from baseline in SCBM/week | Week 1–2, week 3–8, week 9–12, week 9–16, week9-20, week 9-32 | Nonparametric test |
5 | Mean Bristol Stool Scale and change from baseline | Baseline, week 1–2, week 3-8 | Nonparametric test |
6 | Straining degree | Week 1–2, week 3–8, week 9–12, week 9–16, week 9–20, week 9-32 | Nonparametric test |
7 | Time to first SCBM | Time from the first treatment to the first SCBM | Nonparametric test |
8 | Patient assessment of Constipation Quality Of Life (PAC-QOL) | Baseline, week 1–4, week 5-8 | t test or Mann–Whitney U test |