Table of Contents
James W. Freston M.D., Ph.D. Professor of Medicine and Clinical Pharmacology University of Connecticut Health Center
Summary of Possibly Related Treatment-Emergent Adverse Events Reported by ɱ% of Patients
Incidence of Nausea by Severity and Dose
Incidence of Nausea and Vomiting per Treatment Administration with 2 and 4 mg
Percentage of Patients with Related Nausea by Dose Number Patients with at Least 8 Attempts
Nausea Conclusion
Adverse Events Described in Detail in the FDA Briefing Document
Serious Adverse Event (SAE) Reporting
Serious Adverse Events (SAEs)
Adverse Events Identified Where Relationship to Uprima® Questioned by Reviewer
Adverse Events Identified Where Relationship to Uprima® Questioned by Reviewer
Overall Incidence of Serious Adverse Events for Patients Treated with Uprima in the Phase I-III Studies
Primary Reasons for Premature Termination from Study
Premature Termination due to Adverse Events
Adverse Events in Subpopulations
Related Treatment-Emergent Adverse Events Reported by ³5% of Patients by Subgroups
Topics Identified in FDA Briefing Document
Representative ED Patient Population
Topics Identified in FDA Briefing Document
Pharmacokinetic Variability
Topics Identified in FDA Briefing Document
Clinical Relevance of 2 mg
Topics Identified in FDA Briefing Document
Diabetes
Topics Identified in FDA Briefing Document
Discontinuations in Long-Term Studies
Topics Identified in FDA Briefing Document
Hemodynamics
Topics Identified in FDA Briefing Document
Nitrate Interaction
Topics Identified in FDA Briefing Document
Alcohol Interaction
Summary
Summary (cont.)
Summary (cont.)
Summary (cont.)
Summary (cont.)
Conclusions
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