AUS Adverse Event and Special Situation Follow Up Information Request Form for General comsumer/ Patients

For AEs and Special Situations originating from a Non-Interventional Study (NIS) or a program, complete the below:

Program/Study Type: Non-Interventional Study (NIS) Compassionate Use Program Pre-Approval Access (PAA) Program Post-Trial Access Program (PTAP) Market Research and Patient Support Program (MAP)

Protocol/Program Number or MAP Identifier:

Patient Number/Identifier:

1. REPORTER DETAILS *

Note: If available please provide reporter’s occupation. If data privacy allows please provide name, address and/or phone number.

Reporter First Name:

Reporter Surname:

Address:

Post Code:

Country:

E-mail Address:

Telephone Number:

Fax Number:

Physician/ Other:

Has the Therapeutic Goods Administration (TGA) been notified of this report?

TGA reference number if any:

2. PERMISSION TO CONTACT HEALTHCARE PROFESSIONAL (HCP)

If the reporter is a consumer/patient, permission to contact HCP regarding pregnancy/adverse event(s)?

HCP Contact Details:

3. PATIENT DETAILS* Note: If data privacy allows please provide at least one descriptor. Please ensure the patient’s age or age group is capturedwherever possible.

Initials/Name:

Sex

Weight(kg):

Height(cm):

Specify the ethnic origin

Date of Birth:

Age at time of event: Note: In case the birth date is not reported try to allocate the patient to one of the age groups at the time when the adverse events were observed Pre-term and term neonates from 0 to 27 days Infants (or toddlers) from 1 month to 23 month Children from 2 years to 11 years Adolescents from 12 to less than 18 years

Neonates and infants:

Gestational age at delivery:

Week(s)

Maturation of the pediatric patient in the context of the age:

Prematurity:

Yes No

Specify:

Pubertal development delayed:

Yes No

Specify:

Growth:

Percentile below

Percentile above

Cognitive and motor development milestone

Specify:

4. SUSPECT PRODUCT * If more than 4, continue in Additional Relevant Information, Section 8

SUSPECT PRODUCT A

Product Name A (report brand name if available)

Indication / Condition (for which the product has been prescribed)

Dose and Unit

Route

Frequency

Start Date (dd/MMM/yyyy)

Stop Date dd/MMM/yyyy (or ongoing)

Batch / Lot Number

Was the suspect product discontinued due to the adverse event? Yes No

If so, did the patient’s condition resolve/improve? Yes No Unknown

Was the suspect product reintroduced? Yes No

If so, did the event recur? Yes No Unknown

SUSPECT PRODUCT B

Product Name B (report brand name if available)

Indication / Condition (for which the product has been prescribed)

Dose and Unit

Route

Frequency

Start Date (dd/MMM/yyyy)

Stop Date dd/MMM/yyyy (or ongoing)

Batch / Lot Number

Was the suspect product discontinued due to the adverse event? Yes No

If so, did the patient’s condition resolve/improve? Yes No Unknown

Was the suspect product reintroduced? Yes No

If so, did the event recur? Yes No Unknown

SUSPECT PRODUCT C

Product Name C (report brand name if available)

Indication / Condition (for which the product has been prescribed)

Dose and Unit

Route

Frequency

Start Date (dd/MMM/yyyy)

Stop Date dd/MMM/yyyy (or ongoing)

Batch / Lot Number

Was the suspect product discontinued due to the adverse event? Yes No

If so, did the patient’s condition resolve/improve? Yes No Unknown

Was the suspect product reintroduced? Yes No

If so, did the event recur? Yes No Unknown

SUSPECT PRODUCT D

Product Name D (report brand name if available)

Indication / Condition (for which the product has been prescribed)

Dose and Unit

Route

Frequency

Start Date (dd/MMM/yyyy)

Stop Date dd/MMM/yyyy (or ongoing)

Batch / Lot Number

Was the suspect product discontinued due to the adverse event? Yes No

If so, did the patient’s condition resolve/improve? Yes No Unknown

Was the suspect product reintroduced? Yes No

If so, did the event recur? Yes No Unknown

5. ADVERSE EVENTS (S) / SPECIAL SITUATION (S) * Note: If required, continue in Additional Relevant Information, Section 8

Adverse Event (AE) (list primary first)

Onset Date (dd/MMM/yyyy)

Resolved / Improved Date (dd/MMM/yyyy)

Seriousness 1. Death (if yes, provide date): dd/MMM/yyyy 2. Life-Threatening (use only if patient was at immediate risk of death due to adverse event) 3. Initial/Prolonged Hospital Admission 4. Congenital Anomaly/Birth Defect 5. Persistent or Significant Disability 6. Medically Significant ( important medical event that may jeopardize the patient and may require medical/surgical intervention to prevent the other outcomes) 7. Non-serious Adverse Events of Special Interest (AESI) as per protocol 8. Non-serious

Causality Y=Yes, N=No, U=Unknown, NP=Not Provided (specify all suspect products that may have caused the adverse event). If causality is unknown, specify “unknown” and add further details in Section 8

Adverse Event (AE) B

Onset Date (dd/MMM/yyyy)

Resolved / Improved Date (dd/MMM/yyyy)

Adverse Event (AE) C

Onset Date (dd/MMM/yyyy)

Resolved / Improved Date (dd/MMM/yyyy)

6. CONCOMITANT MEDICATIONS

Note: Also include herbal, homeopathic medications and supplements as well as OTC products. If more than 6, continue in Additional Relevant Information, Section 8.

Product Name A (report brand name if available)

Dose and Unit

Indication

Route

Frequency

Start Date (dd/MMM/yyyy)

Stop Date dd/MMM/yyyy (or ongoing)

Product Name B (report brand name if available)

Indication

Route

Frequency

Stop Date dd/MMM/yyyy (or ongoing)

Start Date (dd/MMM/yyyy)

Dose and Unit

7. TEST(S) PERFORMED TO EVALUATE ADVERSE EVENT(S) E.g., baseline results prior to product. If required, continue in Additional Relevant Information, Section 8

Test Product A

Date of Test (dd/MMM/yyyy)

Test Result (include units if applicable)

Reference Range

Result Pending? Yes No

Test Product B

Date of Test (dd/MMM/yyyy)

Test Result (include units if applicable)

Reference Range

Result Pending? Yes No

Test Product C

Date of Test (dd/MMM/yyyy)

Test Result (include units if applicable)

Reference Range

Result Pending? Yes No

Test Product D

Date of Test (dd/MMM/yyyy)

Test Result (include units if applicable)

Reference Range

Result Pending? Yes No

8. ADDITIONAL RELEVANT INFORMATION

500 characters left

Note: Provide a description of the adverse event(s), severity, concurrent conditions and relevant medical history (including start and end date if applicable), clinical course, causality (if unknown), treatment for adverse event(s) and outcome. For pediatric patients, consider the following important information: Pharmaceutical form and strength of product. Dosage prescribed and/or administered (including single/daily and/or total dose, as well as dosing schedule). Duration and circumstances of exposure to product. Method used to determine the dosage. Treatment compliance. Information on maternal and paternal exposure to medicines during conception or pregnancy, as well as exposure of the neonate/infant through breastfeeding.

9. MEDICATION ERROR INFORMATION Note: Complete for all reports of intercepted or confirmed medication error. If any other information is considered of relevance, provide it in section 8

Brief description of the medication error:

Was the patient exposed to the error? Yes If the answer is Yes, continue to section a No If the answer is No, continue to sections band c

a) Did the error have any clinical consequences Yes (If the answer is yes, provide the numbers of the associated adverse events (as per section 5) below:) No

Provide the numbers of the associated adverse events (as per section 5)

c) Describe the potential for harm that might have occurred if the error had reached the patient:

Setting(s) where the error occurred (list more than one if applicable, e.g. pharmacy, hospital, private home):

Contributing factors and root causes:

Mitigating factors that prevented or moderated the progression of the error towards harming the patient:

Corrective and/or preventative actions taken in response to the error: