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.)
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