Adverse Events
Event Description
text
Start Date
date
1= Mild 2= Moderate 3= Severe
integer
Action Taken
boolean
Action Taken: Discontinued permanently
boolean
Action Taken
boolean
Action Taken
boolean
Action Taken
boolean
Action Taken
boolean
1= Resolved, No Sequelae 2= AE still present - no treatment 3= AE still present - being treated 4= Residual effects present - not treated 5= Residual effects present - treated 6= Death 7= Unknown
integer
Stop Date
date
OR: Continuing
boolean
Event Analysis: Relationship to Study Intervention (see Description)
text
Event Analysis: Expected?
text
Event Analysis: Serious Adverse Event?
text
PI Initials
text