Type of Report*—Please choose an option—SpontaneousLiteratureStudyClinical trialOthers
Date first received at Sender (Reporting Date)*
Report version*—Please choose an option—InitialFollow-UpFinal
Serious*—Please choose an option—Seriousnon-serious
Reason for seriousness*—Please choose an option—Patient diedLife threateningHospitalizationProlonged hospitalizationCongenital anomaliesPermanent disabilityRequired intervention to prevent damageOther (Specify) Please specify if you picked other(specify) from the dropdown
Was the case medically confirmed*YesNo
First Name*
Family Name*
Institution*
Department*
Reporter Qualification (profession)*PharmacistPhysicianDentistNursePatientsOthers (Specify) Please specify if you picked other(specify) from the dropdown
Patient Initials*
Age at time of onset*
Gender*MaleFemale
If female (date of last menstruation)*
Body weight (kg)*
Body height (cm)*
Date
Cause
AutopsyYesNo
Relevant medical history
ContinuingYesNoYesNoYesNo
Drug Name
Indication
Free Text
Test
Result
Unit
Onset Date
End Date
Duration
Reaction / event as reported by primary source (reporter)recovered / resolvedrecovering/resolvingnot recovered / not resolvedrecovered / resolved with sequelaeunknown
Outcome of reaction
Is the ADR adequately labelled (SPC)YesNo
Additional Information
Obtain Country
Authorization Number
Authorization Country
Authorization Holder
Pharmaceutical form
Route of administration
Dose
Dosage regimen (dose / time)
Dosage
Characterization
Start of administration
End of administration
Action takenDrug withdrawnDose decreaseDose increaseDose not changedUnknownNot applicable
