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ADVERSE REACTION / LACK OF EFFICACY REPORT FORM
INFORMATION ABOUT PATIENT
Initials
Country
Date of birth
Age (years)
Gender MF
INFORMATION ABOUT AR/LE
AE Category Death of patientLife-threateningHospitalization of ambulatory patient or prolongation of hospitalizationTemporary or considerable disability, invalidityCongenital malformationsNone of the above
Date of report
Description of AR
Onset of AR
End of AR
INFORMATION ABOUT SUSPECTED MEDICINAL PRODUCT (SMP)
SMP (trade name, dosage form)
Single dose and dose frequency
Indication for prescription MedicalSelf-medication
Concomitant Medicines
Therapy date From
Therapy date To
INFORMATION ABOUT SOURCE
Status Health workerMedical representativePatientOther
Address
Phone/Fax
E-mail (required)
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