ETL
RECEIPT, INVESTIGATION AND REPORTING OF ADVERSE DRUG EVENTS, PHARMACOVIGILANCE, POST MARKETING SURVEILLANCE AND PHARMACOEPIDEMILOGIC ASSESSMENTS
EFFECTIVE DATE: ___________
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Confidential · Evans Therapeutics Limited · For Internal Use Only
1
Reporter
2
Patient & Event
3
Drug Details
4
Outcome
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
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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
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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) | Tab | Po | 375mg thrice daily | — | Ongoing | Antibacterial |
| 1 | |||||||
| 2 | |||||||
| 3 |
Concomitant Medication
| Medication | Form | Route | Dose / Freq | Start | Stop | Indication |
|---|---|---|---|---|---|---|
Treatment of Adverse Event
| Treatment / Medication | Form | Route | Dose / Freq | Start | Stop | Notes |
|---|---|---|---|---|---|---|
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Was the suspect drug withdrawn?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If withdrawn, did event/symptom(s):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)
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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) |
Thank you for completing this form. A copy will be sent to your email address
and to Pharmacovigilance@evanstherapeutics.com
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