AUS Adverse Event and Special Situation Follow Up Information Request Form for Pregnant comsumer/patients

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

 

1. REPORTER DETAILS *

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

2. PERMISSION TO CONTACT HEALTHCARE PROFESSIONAL (HCP)

 

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.

Neonates and infants:

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

 

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

SUSPECT PRODUCT A

SUSPECT PRODUCT B

SUSPECT PRODUCT C

SUSPECT PRODUCT D

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

 

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. 

 

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

 

8. ADDITIONAL RELEVANT INFORMATION 

500 characters left

 

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