ADVERSE EVENTS REPORTING FORM

Concord Biotech Limited

B-1601, HN Safal Mondeal Heights,

S.G.Highway, Ahmedabad – 380 015

Gujarat, India.

Contact (Toll free) number as 1800-123 6630

ADVERSE EVENTS REPORTING FORM* fields are required.

Report Type: Initial Follow up Final

A. PATIENT INFORMATION:

12. Relevant tests/ laboratory data with dates*

1. Patient Initials*

 

 

2. Age at time of Event or Date of Birth*

3. Gender:

M

F

4. Weight*  (Kgs)

B.  SUSPECTED ADVERSE REACTION:

13. Relevant medical/ medication history (e.g. allergies, race, pregnancy, smoking, alcohol use, hepatic/renal dysfunction etc.)*

5. Date of reaction started*

(dd/mm/yyyy)

6. Date of recovery*

(dd/mm/yyyy)

7. Describe reaction or problem*

14. Seriousness of the reaction: No if Yes (please tick anyone)

Death (dd/mm/yyyy) Congenital-anomaly

Life threatening Required intervention to Prevent permanent

Hospitalization/Prolonged impairment/damage

Disability Other (specify)

15. Outcomes

Recovered Recovering Not recovered

Fatal Recovered with sequelae Unknown

C. SUSPECTED MEDICATION(S):

 

Sr.#

8. Name (Brand/Generic)

Manufacturer (if known)

Batch#./ Lot #

Exp. Date (if known)

Dose used

Route used

Frequency (OD,BD etc.)

Therapy dates

 

Indication

Causality Assessment

Date started

Date stopped

0

1

2

3

4

Sr#

As per C

9. Action Taken (please tick)

10. Reaction reappeared after reintroduction (please tick)

Drug withdrawn

Dose increased

Dose reduced

Dose not changed

Not applicable

Unknown

Yes

No

Effect unknown

Dose (if reintroduced)

i

 

 

 

 

 

 

 

 

 

 

ii

 

 

 

 

 

 

 

 

 

 

iii

 

 

 

 

 

 

 

 

 

 

iv

 

 

 

 

 

 

 

 

 

 

11. Concomitant medical product including self-medication and herbal remedies with therapy dates (Exclude those used to treat reaction)

S.No

Name

(Brand/Generic)

Dose used

Route used

Frequency (OD, BD, etc.)

Therapy dates

Indication

Date started

Date stopped

0

1

2

3

4

Additional Information*:

D. REPORTER DETAILS

16. Name and Address*:

Pin*:

E-mail*:

Tel. No. (with STD code)*:

Occupation*:

Signature*:

17. Date of this report (dd/mm/yyyy)*:

Declaration

I authorize Concord Biotech Limited and any of the relevant affiliates of the company to collect and analyze the information provided for the purpose of assessing side effects related to my use of a Concord’s product, and to disclose this information as required by law or regulation to health authorities in my country, and other countries around the world. All information concerning this report as well as any follow up queries for additional medical details will be in compliance with the Concord Patient Safety Reporting Privacy Notice. I aware that submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.

Signature/Name of the Reporter*