Efficacy and Safety

3/16/01


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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

Author: Pro ED COMMUNICATIONS, INC.