Advisory Committee Presentation on Vioxx (Rofecoxib) Discussion on the meta analyses for cardiovascular risk assessment

3/7/01


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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

Author: CDER USER