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Table 2 Summary of Responsiveness Results

From: Evaluation of meaningful change in bowel movement frequency for patients with carcinoid syndrome

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
  1. BM Bowel movement, CS Carcinoid syndrome, ISP Interview subpopulation, ITT Intent-to-treat, SES Standardized effect size
  2. aThere were n = 75 “not changed to yes at Week 12”
  3. bThere were n = 10 “a little better”; n = 10 “the same”; and n = 1 “a little worse”
  4. cThere were n = 8 “neither satisfied nor dissatisfied”; n = 3 “somewhat dissatisfied”; and n = 3 “very satisfied”
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