Statistical Considerations on NDA 21-200

3/16/01


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Table of Contents

Statistical Considerations on NDA 21-200

Outline

Background on Clinical Studies

Background on Clinical Studies

Amendments to Protocols

Subject Global Assessment of Abdominal Discomfort/Pain

Definition of Responder for SGA of Abdominal Discomfort/Pain

Amendments to Protocols

Subject Global Assessment of Relief

Definition of Responder for SGA of Relief

Amendments to Protocols

PPT Slide

PPT Slide

PPT Slide

Gender Conclusions

Importance of Abdominal Pain in Evaluating Efficacy

Not Accounting for All Laxative Use Affects the Efficacy Assessment

Reasons Why Pooling is not Appropriate to Demonstrate Efficacy

Reasons Why Pooling is not Appropriate to Demonstrate Efficacy (cont.)

Reasons Why Pooling is not Appropriate to Demonstrate Efficacy (cont.)

Summary

Author: CDER USER