Patient’s initials:

Check the adequate box below:

THE ADVERSE REACTION DETERMINED:

the patient’s deathdisability/ significant or long-lasting incapacityjeopardized the patient’s lifeanomaly/ congenital malformationhospitalization/prolonged hospitalization

YESNO

YESNO

YESNO

YESNO

YESNO

YESNO
SECTION FILLED-IN BY THE PHARMACOVIGILANCE OFFICER FURTHER TO ASSESSING CAUSALITY
certainlyprobablylikelyless likelyunclassifiedunclassifiable

* all fields are compulsory