UPO Loader

Adverse Event

1. Seriousness assessment
Serious Adverse Event (SAE)
2. Initial adverse event (AE) or a follow-up report?
3. Patient
Sex
Date of birth or age
Name or Initials
Phone
Fax
Email
Ethicity/Race
Address
Weight
kg
Height
m
cm
Pregnant
If this is a pregnancy observation, please fill in a Pregnancy Form
4. Suspected drug
Product
Lot / batch no
Expiry date
Formulation and strength
Total daily dose/dose+ frequency
Route (e.g. oral)
Duration of therapy
Indication for use of suspected drug
5. Adverse event
Main diagnosis/syndrome
Start date
Stop date
Overall Outcome
Causality
Severity
If patient died, cause of death
Autopsy report
If patient recovered with sequelae, please specify
6. If AE is serious, please tick all appropriate to AE(s)
7. Date of hospitalisation
8. Date of discharge
9. Description of AE(s)
Diagnosis, signs, symptoms, course of event(s), drugs used for treatment and other examinations/treatments performed.
10. Dechallenge and rechallenge for suspected drug
Was treatment with product stopped due to the event(s)?
Did reaction(s) stop after discontinuing the drug?
Did reaction(s) reappear after reintroduction of the drug?
11. Has the patient previously been exposed to the suspected drug?
Did any AE(s) occur then?
12. Concomitant medication:
Drug(s)
Formulation and strength
Total daily dose/ dose+ frequency
Formulation and strength
Route(e.g. oral)
Duration of therapy
Indication for use of concomitant drug
13. Are any of the concomitant medications suspected of being causally related to the AE?
Did the AE disappear after stop of drug?
Did the AE reappear after restart of drug?
14. Relevant medical history: (e.g. previous diagnoses, surgery, allergies)
Disease, surgical procedure, etc.
Start date
Continuing:(Y/N/Unknown)
End date
Comments
15. Relevant clinical/laboratory assessments
Test(s)
Assessment date
Results
Unit
16. Reporter
Reporter’s name
Institution
Address
Date
Profession
Country
Phone
Fax
Email
17. May the reporter be contacted again if necessary
Submit