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 )
PPT Slide
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
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