James W. Freston M.D., Ph.D. Professor of Medicine and Clinical Pharmacology University of Connecticut Health Center

5/4/00


Click here to start


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 │5% 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

Author: Andrea_Poffenberger