ReportType: {Spontaneous} {PSP} {Market Research} Country of Occurrence:

{EAP} {Other} {USA}

Contact Information for Receiver of Safety Information:

Date Report Received: Report Received By (print name): Vendor Name or {VendorName}
{Date Report Received} {Report Received By}
Receiving Person's Receiving Person’s Phone #: Vendor Case ID # or {VendorCaseID}
E-mail: {ReceivingPersonsPhone}
{ReceivingPersonsemail}
Reporter Information:
Reporter (name): Reporters Address: Reporter is:
{ReporterName} {Reporters_Address__c} {Patient}
Phone #: {Phone__c} Country: {Healthcare Professional}
Fax #: {Fax__c} {Country} {Other1}
Reporter’s e-mail
address:
{Reporters_email__c}
***If reporter is not the prescriber, enter Physician’s Information, Consent to contact HCP for additional information?
if available
{ContactHCPforadditionalinfo}
Name of Physician: Phone #:
{NameofPhysician} {PhysicianPhone}
Fax #: Email address:
{PhysicianFax} {EmailAddress}
Patient Information:
Patient Date of Gender: Age: Age group: Consent to contact patient for
Initials: Birth: {Gender} {Age} {Agegroup} additional information?
{Patient {Date of {ContactPatientforadditionalinfo}
Initials} Birth}
Intercept Product Information:
Product Name: {ProductName} Indication for Use: Drug Start Date:
Dose at initiation: Frequency: Route: {IndicationForUse} {DrugStartDate}
{Dose at initiation} {1 per Day} {InitiationRoute} Drug Stop Date:
{1 per Week} {DrugStopDate}
{2 per Day}
{2 per Week}

Dose at time of event: Frequency: Route: Lot #: Expiration Date:

{DoseAtTimeOfEvent} {1 per Day1} {EventRoute} {Lot__c} {ExpirationDate}
{1 per Week1}
{2 per Day1}
{2 per Week1}
{childContent}
DESCRIPTION OF THE EVENT(S): {DescriptionoftheEvent}

Concomitant Medications (Include daily dose and dates of administration and indicate if co-suspect medication):
Medication
Daily Dose Start Date Stop Date Co-Suspect? Y/N Adverse Event
Name:
{MedicationName} {DailyDose} {StartDate} {StopDate} {CoSuspect} {AdverseEvent}
Medical History: {MedicalHistory} Relevant Diagnostic Test / Laboratory Results:
{RelevantDiagnosticTestLabResults}
Product Complaints?
{ProductComplaints} If yes, describe product complaint: {ProductComplaintDescription}