Table 1.
Summary of Meaningful Change Thresholds
| Parameter | Threshold for Acceptability | Analysis Population | Average Number of Daily BMs | |||||
|---|---|---|---|---|---|---|---|---|
| Overall Change from Baseline | Change from Baseline at Week 12 | |||||||
| N | ES | Mean | N | ES | Mean | |||
| Anchor-based Meaningful Change Thresholds | ||||||||
| Adequate relief (changed to Yes at Week 12) |
Effect Size: -Small (≥ 0.2) -Moderate (≥ 0.5) -Large (≥ 0.8) |
ITT | 19 | −1.20 | −1.90 | 18 | −1.58 | −2.52 |
| EORTC QLQ-C30 Diarrhea (Responder) | ITT | 45 | −0.83 | −1.71 | 40 | −1.24 | −2.56 | |
| EORTC GI.NET21 GI Symptoms (Responder) | ITT | 30 | −1.25 | −1.88 | 25 | −1.49 | −2.27 | |
| Distribution-based Meaningful Change Thresholds | ||||||||
| −1/2 Baseline SD | N/A | ITT | 135 | N/A | 0.62 | 108 | N/A | 0.86 |
BM Bowel movement, EORTC QLQ-C30 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire, ES Effect size, ITT Intent-to-treat, N/A Not applicable, SD Standard deviation