Table of Contents
Advisory Committee Presentation on Vioxx (Rofecoxib) Discussion on the meta analyses for cardiovascular risk assessment
PPT Slide
Key Features of the Meta Analysis
Issue of the Meta Analysis
Concerns of the Meta Analysis
Concerns of the Meta Analysis
Rofecoxib Exposure Data from Meta Analysis Data Sets
Summary of Limitations
Conclusions
Three Comparisons
Sample Sizes for Studies at Least 6-month Duration
The Assessment of CV Risk on Lower Doses of Rofecoxib
Preliminary Dose-response Assessment provided by sponsor including studies with duration longer than 6 months
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