Gastrointestinal Review Highlights of the CLASS Study

3/6/01


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Table of Contents

Gastrointestinal Review Highlights of the CLASS Study

Outline of Gastrointestinal Review of CLASS study

Outline of Gastrointestinal Review of CLASS study (continued)

Design Highlights

Statistical Plan

Statistical plan (continued)

Endpoint Definition “Complicated Ulcer”

“Traditional” Definition

Traditional definition of bleeding (continued)

Design highlights (continued)

Design highlights (continued)

Design Highlights (continued)

Design Highlights

Design Highlights Conclusions

Results

Primary endpoint Complicated Ulcer : ITT

Time to Complicated Ulcer (CSUGIE )

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Subanalyses: Complicated Ulcers Non-ASA and ASA users

Non-ASA

Time to Complicated Ulcer (CSUGIE)

PPT Slide

Complicated Ulcer ASA

Summary of Findings for Complicated Ulcers

Other Relevant Analyses Composite Endpoint (SX/Complicated)

Composite Endpoint (SX/Complicated)

Composite Endpoint SX/Complicated Ulcer ITT

Time to Composite: SX/Complicated Ulcer

PPT Slide

Composite:SX/Complicated Ulcer Non-ASA

Time to Composite: SX/Complicated Ulcer

PPT Slide

Composite: SX/Complicated Ulcer ASA

Conclusions of Composite: SX/Complicated Ulcer

Conclusions of Composite: SX/Complicated Ulcer (continued)

“Alternate” Definition of Bleed/Major Bleed

Complicated Ulcer Using Pre-specified “Alternate” more serious definitions of Bleed/Major Bleed

High risk populations Relative Risk Complicated ulcer

High risk populations Relative Risk Composite: SX/Complicated ulcer

High Risk Populations

Overall Conclusions

Overall Conclusions (continued) Hypothesis Generating Findings

Overall Conclusions (continued) Hypothesis Generating Findings

Overall Conclusions (continued)

Overall Conclusions

PPT Slide

Author: CDER USER