Table of Contents
Efficacy and Safety
Overview of Clinical Results
Tegaserod Clinical Program in Constipation-Predominant IBS
Efficacy Presentation
Phase II Study Design (B251)
Phase II Subject’s Global Assessment (SGA) of Overall GI Symptoms (B251)
Phase III Design Considerations Outcome Measures in IBS Trials (1)
Outcome Measures in IBS Trials (2)
Phase III Study Designs
Inclusion Criteria
Exclusion Criteria
Randomization Criteria
Primary Efficacy Variable SGA of Relief (B351)
Primary Efficacy Variable SGA of Abdominal Discomfort/Pain (B351)
Statistical Methodology for Primary Efficacy Variables
Adjustment Rules
Secondary Efficacy Assessments
Patient Disposition
Demographics
Baseline Characteristics
Efficacy Results Presentation Overview
SGA Data Presentation
Primary Efficacy Variables at Endpoint (B351)
Complete or Considerable Relief by Week (B351)
SGA of Abdominal Discomfort/Pain by Week (B351)
SGA of Bowel Habit (B351)
Daily Diary: Abdominal Discomfort/Pain (B351)
Daily Diary: Bloating (B351)
Number of Bowel Movements and Stool Consistency by Week (B351)
Summary (B351)
Modification of Primary Efficacy Variables
Associations Between SGA of Relief and Other Efficacy Variables (B351)
Associations Between SGA of Relief and Other Efficacy Variables (B351)
Modification of Primary Efficacy Variables for Studies B301/B307
Efficacy Results SGA of Relief (B351)
Study B301 Efficacy Results
Study Design (B351 and B301)
SGA of Relief at Endpoint (B301)
SGA of Relief at Endpoint
Monthly SGA of Relief
At Least Somewhat Relief by Week
SGA of Abdominal Discomfort/Pain (B301)
SGA of Bowel Habit (B301)
Daily Diary: Abdominal Discomfort/Pain (B301)
Daily Diary: Bloating (B301)
Number of Bowel Movements and Stool Consistency by Week (B301)
Summary Study B301
Study B307 Efficacy Results
Study Design (B307)
SGA of Relief (B307)
At Least Somewhat Relief by Week (B307)
SGA of Abdominal Discomfort/Pain (B307)
SGA of Bowel Habit (B307)
Number of Bowel Movements and Stool Consistency by Week (B307)
Summary Study B307
Comparative Efficacy Summary
Phase III Studies At Least Somewhat Relief
Phase III Studies Complete/Considerable Relief
Efficacy Variables at Endpoint
Additional Analyses
Pooled Analysis
Number of Months With Positive Response for SGA of Relief§
% Weeks With At Least Somewhat Relief
SGA of Relief by Gender Pooled Results: B351/B301/B307
SGA of Relief at Endpoint Placebo-Subtracted Values by Gender
Summary of Efficacy (1)
Summary of Efficacy (2)
Summary of Efficacy (3)
Safety
Safety Overview
Overall Exposure
Serious Adverse Events
Reasons for Discontinuations (Phase III)
Overall Adverse Events (Phase III)
Adverse Events > 5% (Phase III)
Time to First Episode of Diarrhea (Phase III)
Adverse Events (? 1%) Leading to Discontinuation (Phase III)
Long-Term Safety Study (B209)
Adverse Events > 5% (Long-term Study: 12 Months)
Adverse Events (> 1%) Leading to Discontinuation (Long-term Study)
Laboratory Evaluations (Phase III)
ECG Recording and Analysis
Safety Summary
Conclusions
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