Table 2.
Correlation of adequate relief with symptom-specific and global endpoints at week 12
| Symptom | Correlation with adequate relief |
|---|---|
| Abdominal symptoms (percentage change from baseline) | |
| Abdominal pain | 0.50 |
| Abdominal discomfort | 0.54 |
| Abdominal bloating | 0.52 |
| Abdominal fullness | 0.54 |
| Abdominal cramping | 0.48 |
| Bowel symptoms (change from baseline) | |
| CSBMs/week | 0.38 |
| SBMs/week | 0.34 |
| Straining | 0.39 |
| Stool consistency | 0.32 |
| Global endpoints | |
| IBS degree of relief | 0.71 |
| IBS severity | 0.62 |
| Constipation severity | 0.61 |
| Treatment satisfaction | 0.70 |
Absolute values are given for the correlations; p < 0.0001 for all correlations. CSBM: complete spontaneous bowel movement; IBS: irritable bowel syndrome; ITT: intent to treat; NRS: numerical rating scale; SBM: spontaneous bowel movement. Week 12 last observation carried forward (LOCF), pooled phase 3 IBS-C ITT population; patients with a baseline score of <3 (on the 0- to 10-point NRS) for an abdominal symptom were excluded from the analysis of that symptom; patients with a baseline score of <2 for straining, >3 for stool consistency, or a missing stool consistency or straining score (i.e. due to 0 SBMs) were excluded from the analysis of that parameter.