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Re: Global Case ID: TH201410002544 (Local Case ID: TH141000672), FU #4
Thank you for reporting to us an adverse event related to Lilly product(s).
We would like to collect more information to better understand the reported event.
Please respond to following questions regarding the serious adverse event – urinated more often, had an early stage of renal disease, had urinary tract infection, and found red blood cell in urine, involving a Female patient, 60 yrs., who was subscribed Teriparatide, reported the event to Lilly on 2 -July-2015. (#3152)
Thank you.
Yours sincerely,
Sasithorn Suntharo
ELI LILLY AND COMPANY
Pharmacovigilance Associate
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Please provide the information by 22-Sep-2015:
1. Please confirm Teriparatide start date (02-Jun-2013 or 02-Jun-2014)
2. If possible, please provide the stage of the early renal disease as well as relevant laboratory tests.
3. Please provide risk factors for renal disease
4. Please provide etiology of renal disease
5. If possible, please provide the results from the test performed in Jun-2015 which indicated red blood cells in urine.
6. Please provide the cause of red blood cells in urine.
Name of HCP/ Initial Reporter:
Signature:
Date:
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For Eli Lilly Internal Use Only
Reporter (Name and Designation):
Date of Confirmation of FU request sent to HCP:
For Asia PhV Central Office Use Only:
Awareness Date (dd/mmm/yyyy) of this FU report:
Information received from:
☐ Call Centre
☐ Sales Representative
☐ Others, please specify:_____________________________
Method of information received:
☐ email (Please attach the email for documentation)
☐ Hard Copy
☐ Call (Please attach the communication log for documentation)
☐ Others, please specify: ______________________