Placebo (ITT) | Linaclotide (ITT) | Change from baseline Δ | P -value (ITT) | Placebo (IS) | Linaclotide (IS) | Change from baseline Δ | P-value (IS) | |
---|---|---|---|---|---|---|---|---|
Overall (n) | 795 | 803 | 5.2 | <0.0001* | 249 | 273 | 7.2 | 0.0007* |
Baseline | 68.9 (31.9) | 66.9 (30.9) | 27.2 (17.8) | 29.5 (17.7) | ||||
Week 12 | 79.7 (25.9) | 83.1 (23.6) | 57.8 (29.9) | 67.9 (28.1) | ||||
Females (n) | 706 | 733 | 5.2 | <0.0001* | 228 | 256 | 6.7 | 0.0016* |
Baseline | 68.0 (32.3) | 66.1 (31.1) | 26.6 (17.8) | 29.5 (17.8) | ||||
Week 12 | 79.8 (25.8) | 83.2 (23.4) | 58.5 (30.2) | 68.6 (27.7) | ||||
Males (n) | 89 | 70 | 4.2 | 0.3129* | 21 | 17 | 10.2 | 0.2389* |
Baseline | 76.3 (28.1) | 74.5 (28.7) | 32.7 (16.5) | 30.1 (17.7) | ||||
Week 12 | 78.9 (26.7) | 81.5 (26.0) | 50.0 (25.7) | 57.8 (33.2) |
Data are mean (SD)
↵* P-values based on change-from-baseline treatment difference for linaclotide vs placebo (ANCOVA)