Gastrointestinal Review Highlights of the VIGOR Trial

3/7/01


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Table of Contents

Gastrointestinal Review Highlights of the VIGOR Trial

Outline of Presentation

VIGOR Study Design

Primary study hypotheses

Endpoint definitions

Confirmed Event PUB Any one of the following four clinical presentations

Confirmed Event PUB (continued)

Confirmed Event PUB (continued)

Confirmed Complicated Event PUB

Results

PPT Slide

Confirmed Complicated PUBs

Types of Confirmed PUBs

Subanalysis by Risk factor Prior history of PUB

Subanalysis by Risk factor Age

High risk populations

High risk populations

GI Risk in special populations Other questions

Generalizability of GI Safety

Data from phase IIb and III studies

Data from phase IIb and III studies

Meta-analysis of cumulative PUB IIb and III Studies

Conclusion of meta-analysis of phase IIb and III studies

Overall Conclusions

Overall Conclusions

Author: CDER USER