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
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