Adverse Event Reporting Form

A. PATIENT INFORMATION

Patients Initials
Country
Date
Report Type
Date Of Birth
Age
Race
Sex
Height
Weight
Onset Date
Recovery Date

B. ADVERSE EVENT INFORMATION

Seriousness criteria

History

Patient’s Relevant Medical History

(e.g. co-existing medical conditions such as disease, allergies, similar experience)

C. DRUG INFORMATION

Product Name

Brand Name
Generic Name

Therapy Dates

From
To
Manufacturer
Batch / Lot Number
Expiry Date
Dose
Route of use
Frequency
Indication

D. CONCOMITANT DRUGS

Drug Name

Brand Name (s)
Generic Name

Therapy Dates

From
To
Dose
Reason for use

Action Taken With Suspect Drug

Did Reaction Disappear After Stopping of Drug ?

Did Reaction Reappeared After Restarting of Drug ?

Outcome Of The Patient / Ae

ASSESSMENT OF CAUSALITY

E. REPORTER’S INFORMATION

Name
Tel. no.
Date of this Report
Email
Address

Senders Contact Details :

Inga Laboratories Private Limited, Mahakali Road,
Andheri East, Mumbai - - 400 093, INDIA.
Tel.: 91-22 2820 2932 / 33,
Fax: 91-22 2836 4049
Email Id: Medicalservices@ingalabs.com

+91-22-28202932 / 33