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