Fig 1.
Consolidated Standards for Reporting of Trials flow diagram.
Table 1.
Grading of stool consistency and diarrhea severity.
Table 2.
Demographics and baseline characteristics of the safety population.
Table 3.
Study drug–related treatment-emergent adverse events by system organ class and preferred term in the safety population.
Fig 2.
Reverse cumulative distribution plot for diarrheal stool output rate overall in the modified intent-to-treat population.
The curve for the iOWH032 is shifted to the left of the placebo group, indicating a lower diarrheal stool output rate; however, this difference was not statistically significant (Van Elteren test: p = 0.2254).
Table 4.
Diarrheal stool output rate overall and by blood type status in the modified intent-to-treat population.
Table 5.
Diarrheal disease severity by treatment group for the modified intent-to-treat population.
Table 6.
Secondary efficacy endpoints for the modified intent-to-treat population.
Fig 3.
Scatterplot of iOWH032 plasma concentrations versus diarrheal stool output rate.
Blue dots: plasma levels at 7 hours after dose 1; orange dots: plasma levels at 7 hours after dose 9. Dotted lines: linear regression plots. The Pearson correlation coefficients for these lines are –0.2997 for post dose 1 data and –0.3937 for post dose 9 data.