VIOXX™ Gastrointestinal Outcome Research (VIGOR) Arthritis Advisory Committee Meeting February 8, 2001

3/7/01


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Table of Contents

VIOXX™ Gastrointestinal Outcome Research (VIGOR) Arthritis Advisory Committee Meeting February 8, 2001

Rofecoxib Overall Safety

VIGOR General Safety

VIGOR General Safety Deaths

Definition of Serious AE’s

VIGOR General Safety Serious AE’s (?ɭ%)

VIGOR General Safety Dropouts due to AE’s (?ɭ%)

VIGOR General Safety Lab AE’s

VIGOR General Safety Hospitalizations

VIGOR General Safety Pre-specified NSAID-related AE’s

VIGOR General Safety Summary

Rofecoxib Overall Safety

Time to event plot. Adjudicated serious CV thrombotic events in VIGOR

Serious CV/thrombotic Events Definitions

VIGOR Adjudicated Serious CV thrombotic Events Included for Analyses

VIGOR Serious CV thrombotic events Three Different Endpoints

VIGOR CV Safety Hypotheses

VIGOR CV Safety Hypotheses (2)

Rofecoxib CV Safety Important Limitations to Sponsor’s Meta-analysis

Rofecoxib Exposure Data from Meta Analysis Data Sets

Rofecoxib CV Safety Summary

Rofecoxib Overall Safety

Rofecoxib Risk/benefit Assessment

Study 1021 Preliminary safety data

Rofecoxib Risk/benefit Assessment Co-use with low dose ASA Summary

Rofecoxib Overall Safety

Rofecoxib Overall Safety Post-marketing Surveillance

Rofecoxib Overall Safety

Rofecoxib Overall Safety Conclusions (1)

Rofecoxib Overall Safety Conclusions (2)

PPT Slide

Author: CDER User