Table of Contents
Review of Tirilazad Safety
Outline
Limitations to the Safety Review
20 Day and 91 Day Mortality by Neurograde, Studies 0063 and 0065
Frequency of Serious Adverse Event COSTART Term “Edema Brain” by Neurograde and Study, Studies 0063 and 0065
20 Day Mortality - Phase II SAH Studies
Mortality in SAH Safety Studies without a Vehicle Control
Acute Ischemic Stroke Indication
Mortality Risks by Time Since Study Entry, Ischemic Stroke Studies 88 and 81
Primary Cause of Death for Deaths by Study Day 10, Ischemic Stroke Studies 88 and 81
Head Injury Indication
Mortality Risk by Study Period for Dosed Patients, Head Injury Studies 0036 and 0017
Head Injury Mortality - Study 0017
Cause-specific Mortality Relating to Elevated Intracranial Volume, Head Injury Study 0017
Mortality in Non-SAH Indications
Summary
Acknowledgements
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Author: Judy Racoosin
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