Adverse experience
Adverse experience
boolean
Onset Date and Time
datetime
End Date and Time
datetime
Outcome
integer
Experience Course
integer
Experience Course
integer
MILD Adverse experience which is easily tolerated MODERATE Adverse experience sufficiently discomforting to interfere with daily activities SEVERE Adverse experience which prevents normal everyday activities
integer
Action Taken
integer
RELATED There is a direct cause and effect relationship between the adverse experience and the study drug POSSIBLY RELATED A direct cause and effect relationship between the drug and the adverse experience has not been demonstrated but is possible or likely PROBABLY UNRELATED Cause and effect relationship between the drug and the adverse experience has not been demonstrated, is improbable but not impossible UNRELATED The adverse experience is definitely not related to the test drug
integer
If ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
boolean
Patient withdrawal
boolean
Pregnancy information
Study conclusion
Study completion
integer
Study completion
integer
If yo answered the previous question with 'other', please specify:
text
Administration Investigator
I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Adverse Experience and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.
text
Date
date