Review of Tirilazad Safety


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Table of Contents

Review of Tirilazad Safety


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



Author: Judy Racoosin