Medical Supplies & Services

Adverse Event Complaint Form

Type of report

Primary

Follow up

Name of medical Dept. contact person

Date

Primary Reporter’s Information

Name

Profession

Address

Title

Phone No*

Fax

Patient’s Information

Initials

Gender

Male Female

Age

Height

Weight

Date of birth

Drug(s) Information

Brand

Indication

Lot

Route

Start date

Expiry Date

Dose:(Unit –Freq- Period)

Stop date

Comment

Out come and possible relatedness of drug

Did the event resulted in one of the following:

Death

Hospitalisation

Disability

Life threatening

Congenital anomaly

Others

Possible relatedness of study drug in physicians discretion

Yes

Don’t Know

Final Outcome:

Fully Recovered Recovering Not yet recovered Recovered with sequel

Concomitant Medication(s)

Please do not list drugs used to treat this Adverse Event

Brand Name

Daily Dose:

Indication

Concomitant Medication(s)

Details of Adverse Event“Event Summary Description”:

Relevant past history

Abnormal Laboratory values

Lab. test	Result	Normal range