Table 2.
Summary of Responsiveness Results
| Parameter | Threshold for Acceptability | Analysis Population | Average Daily BMs | |||
|---|---|---|---|---|---|---|
| Overall Change from Baseline | Change from Baseline at Week 12 | |||||
| N | SES | N | SES | |||
| Responsiveness (SES) | ||||||
| Adequate relief (changed to Yes at Week 12)a |
Standard Effect Size: -Small (≥ 0.2) -Moderate (≥ 0.5) -Large (≥ 0.8) |
ITT | 19 | −0.99 | 18 | −1.40 |
| Perception of change in BMsb | ||||||
| A great deal better | ISP | 9 | −1.44 | 8 | −1.80 | |
| Much better | ISP | 4 | −0.50 | 4 | −0.60 | |
| Satisfaction with study medication—Relief of CSc | ||||||
| Very satisfied | ISP | 12 | −1.18 | 12 | −1.38 | |
| Somewhat satisfied | ISP | 7 | −0.15 | 6 | −0.38 | |
BM Bowel movement, CS Carcinoid syndrome, ISP Interview subpopulation, ITT Intent-to-treat, SES Standardized effect size
aThere were n = 75 “not changed to yes at Week 12”
bThere were n = 10 “a little better”; n = 10 “the same”; and n = 1 “a little worse”
cThere were n = 8 “neither satisfied nor dissatisfied”; n = 3 “somewhat dissatisfied”; and n = 3 “very satisfied”