Ae-ETDC

Suspected Adverse Event Reporting

You are about to begin the Suspected Adverse Event Reporting. Please fill all the required information carefully.

Patient Information

Please provide patient information correctly.

Age *

Weight (Kgs) *

Any pre-existing medical condition *

Extent

Mild

Moderate

Severe

Product Information

Name of Product and strength *

Route *

Therapy Dates *

Daily Dose *

Indication *

Batch no *

Did reaction stopped after stopping / changing the dose: *

Did the reaction reappear after drug was reintroduced *

Product available for evaluation *

Event Information

Date of Onset *

Describe the event with relevant lab tests or any data known *

You consider the problem related to which of the following

Adverse Event / Reaction

Quality Problem

Medication error

Other

Please specify *

Do you consider this event serious *

Please indicate why? *

Please Specify *

Other Drug(s)/ Alternative medicine(s) and history

Concomitant drugs used (if any) (exclude those used to treat reaction)

Other Relevant History (diagnosis, lab tests, etc.)

Reporter Information

Reporter’s Name *

Contact details *

Profession *

Affiliation *

Mailing address *

Date reported *

Thank you very much for reporting.

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