Non-Serious Adverse Events
NOTE: If this is a Serious Adverse Event (SAE), do not complete this form, do to the SAE section and complete the SAE form.
boolean
If Yes, record details below.
text
Non-Serious Adverse Events Chart
Diagnosis only (if known) otherwise sign/symptom e.g., Headache
integer
Start date
date
e.g., 1
integer
End date
date
Frequency
integer
Maximum Intensity
text
Action taken with Investigational Product(s) as a result of the Non-Serious AE
text
Did the subject withdraw from study as a result of this AE?
boolean
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Complete Study Conclusion page and mark Adverse event as reason for withdrawal.
text