ADR Form

Evans Therapeutics – Adverse Event Report
ETL
RECEIPT, INVESTIGATION AND REPORTING OF ADVERSE DRUG EVENTS, PHARMACOVIGILANCE, POST MARKETING SURVEILLANCE AND PHARMACOEPIDEMILOGIC ASSESSMENTS
EFFECTIVE DATE: ___________
Page 1–4 of 4
Confidential  ·  Evans Therapeutics Limited  ·  For Internal Use Only
1
Reporter
2
Patient & Event
3
Drug Details
4
Outcome
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Reporter’s Details
Section 1 of 4 — Contact information of the person completing this form
Accurate information on the event(s) experienced by your patient is of great importance in evaluating the safety of our products. The information obtained will be entered onto our safety database. Please complete all sections as fully as possible.
Regulatory Authority Reporting
Evans Therapeutics Limited EQP/8301/F/01  ·  Page 1 of 4
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Patient Details & Adverse Event
Section 2 of 4 — Patient demographics and event description
Patient Information
Patient Identification
(name, initials, medical no.)		 Date of Birth Age Weight (kg) Height (cm)
⚠️
Adverse Event
Describe the event in as much detail as possible
Evans Therapeutics Limited EQP/8301/F/01  ·  Page 2 of 4
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Drug Details
Section 3 of 4 — Suspect medications, concomitant drugs, withdrawal information

Code: Y = Yes  ·  N = No  ·  U = Unknown

Suspect Medications
# Medication (Trade / Generic) Form Route Dose / Frequency Start Stop Indication
e.g. Amovin (Amoxycillin Clav. Acid) TabPo 375mg thrice daily —Ongoing Antibacterial
1
2
3
Concomitant Medication
MedicationFormRouteDose / FreqStartStopIndication
Treatment of Adverse Event
Treatment / MedicationFormRouteDose / FreqStartStopNotes
Drug Withdrawal & Re-introduction
Was the suspect drug withdrawn?
Drug (1)
Drug (2)
Drug (3)
If withdrawn, did event/symptom(s):
Was the suspect drug subsequently re-introduced?
Drug (1)
Drug (2)
Drug (3)
Did events/symptoms recur on re-introduction?
Drug (1)
Drug (2)
Drug (3)
Was the dose of the suspect drug reduced / changed?
Drug (1)
Drug (2)
Drug (3)
If reduced/changed, did event/symptom(s):
Has the patient received the suspect drug(s) before?
Drug (1)
Drug (2)
Drug (3)
Evans Therapeutics Limited EQP/8301/F/01  ·  Page 3 of 4
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Outcome & Causality
Section 4 of 4 — Event outcomes and causality assessment
Event Seriousness
Was the event(s) fatal?
Autopsy Performed?
If patient died — Cause of Death
Was the event life-threatening?
Required or prolonged hospitalisation?
Severely / permanently disabling?
Congenital anomaly / birth defect?
Jeopardised patient or required intervention to prevent above outcomes?
Event Outcome to Date
Causality Assessment

Do you think the relationship between the suspect drug(s) and adverse event(s) was — please complete for each suspect drug:

Suspect Drug Unrelated Unlikely Possible Probable Almost Certainly Related
(1)
(2)
(3)
⚠ DO NOT PHOTOCOPY
Controlled copies to:
Master File  ·  Regulatory File  ·  Quality Assurance  ·  Human Resources  ·  Sales & Marketing

Thank you for completing this form. A PDF copy will be sent to your email address
and to Pharmacovigilance@evanstherapeutics.com

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