Post-Marketing Adverse Event Case Report Form

1. Patient Information

Patient Initials:

Sex:

Age/Date of Birth:

Weight (kg):

Other Relevant Information:

2. Adverse Event Information

Description of Event(s):

Date of Onset:

Seriousness (Yes/No, if Yes, specify):

Outcome:

Other Relevant History/Conditions:

3. Suspected Product(s) Information

Product Name:

Batch/Lot Number:

Dosage/Form/Route:

Start Date:

Stop Date:

Indication for Use:

4. Concomitant Medication(s) / Other Products

Medication Name(s) & Details:

5. Reporter Information

Name:

Occupation:

Contact Information:

Institution/Facility:

Date of Report: