FlexerilŽ MR (Cyclobenzaprine) Actual Use Trial and Safety Review

8/10/99


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Table of Contents

FlexerilŽ MR (Cyclobenzaprine) Actual Use Trial and Safety Review

FlexerilŽ MR Actual Use Trial and Safety Review

Actual Use

Actual Use Studies Background

Actual Use Issues for FlexerilŽ MR

Study Design

Study Design (cont.)

Study Design (cont.)

Study Design (cont.)

Results (N=468)

PPT Slide

PPT Slide

Results: Usage Analysis

Adherence to Instructions Do Not Drive (N=235)

Adherence to Instructions Operate Machinery Warning (N=235)

Actual Use Study Conclusions

Clinical Trial Safety Data Base

Safety Data Base

Safety Data Base - Demographics (cont.)

Safety Data Base - Adverse Events (AEs)

Safety Data Base: Death Case Report

Safety Data: Cyclobenzaprine AEs with Incidences > 3%

Safety Data Base

Safety Data Base Conclusions

Postmarketing Surveillance Data

Postmarketing Surveillance Data

Postmarketing Surveillance Data

Postmarketing Surveillance Data

Postmarketing Surveillance Data: Drug-Drug Interactions

Postmarketing Surveillance Data - Published Literature

Postmarketing Surveillance Data Conclusions

Postmarketing Surveillance Data Conclusions (cont.)

Author: CDER User