Reportable Event Preview

This document contains information about an adverse event report, including the reporter's contact information, patient information, details about the intercept product and event, concomitant medications, medical history, and diagnostic results. It provides the name of the product, dose, route, and dates of administration. The description of the event and relevant history are also included in 3 sentences or less.

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Reportable Event Preview

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Commercial Partner Portal

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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}