Adverse Events
Adverse Event
text
Start Date
date
Stop Date
date
Severity
text
Relationship to Study Treatment
text
1= None 2= Discontinued permanently 3= Discontinued temporarily 4= Reduced Dose 5= Increased Dose 6= Delayed Dose
integer
1= Resolved, No Sequel 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
Expected?
boolean
Serious Adverse Event
text
Initials
text