Fig 1.
Patient Flow Through the Trial.
Screen failures who were rescreened and failed a second time during the screening period were counted once as screen failures. Screen failures who were rescreened, entered the baseline period, and then failed during the baseline period were counted once as pretreatment failures.
Table 1.
Summary of Patient Demographic and Baseline Characteristics (ITT Population).
Fig 2.
Intent-to-treat Population; Responder = patient who had ≥ 3 CSBMs and an increase of ≥ 1 CSBM from baseline, in the same week, for at least 9 of the 12 treatment-period weeks. Note: Primary endpoint for linaclotide 145 μg vs. placebo; secondary endpoint for linaclotide 290 μg vs. placebo. CSBM = complete spontaneous bowel movement; ITT = intent to treat; Lin = linaclotide; n = number of patients meeting the responder endpoint; N = number of patients in the ITT population. * P < 0.05; P values were obtained from a Cochran-Mantel-Haenszel test controlling for geographic region, comparing each linaclotide dose vs. placebo in a pairwise manner.
Table 2.
Efficacy Results During the 12-week Treatment Period (ITT Population).
Fig 3.
Percent Change from Baseline in Abdominal Bloating by Week.
Intent-to-treat Population; % change from baseline in abdominal bloating during each week of the treatment period. % changes from baseline are the least-squares means from an analysis of covariance (ANCOVA) model. Note: % change from baseline in abdominal bloating at each treatment period week was an additional endpoint for both linaclotide dose groups vs. placebo. Both linaclotide doses are associated with greater improvement than placebo at all individual treatment weeks (all reported individual P values < 0.05 for both linaclotide groups vs. placebo; P values were obtained from an ANCOVA model with treatment group and geographic region as factors and baseline abdominal bloating score as a covariate).
Fig 4.
Incremental Percent Improvement in Abdominal Bloating at Week 12.
Intent-to-treat Population; % improvement in abdominal bloating at week 12 (end of the treatment period). Note: The distribution of % improvement in abdominal bloating at week 12 was a secondary endpoint for both linaclotide dose groups. (P < 0.01 for both linaclotide groups vs. placebo; P values were obtained from a Kolmogorov-Smirnov test for equality of distribution.)
Table 3.
Adverse Events During the Treatment Period (Safety Population).