PLEASE PRINT THE LETTER IN AN INSTITUTION LETTER HEAD

Jakarta,24
October 2014
No. of Letter: <Departments reference number for correspondence>
To:
Prof. Dr. dr.Rianto Setiabudi, SpFK
Chairman of Ethics Committee Faculty of Medicine University of Indonesia
Jalan Salemba Raya No.6
Jakarta, 10430 Indonesia
Protocol No: 1245.25
A Phase III, multicentre, international, randomised, parallel group, double
blind cardiovascular safety study of BI 10773 ( 10 mg and 25 mg
administered orally once daily ) compared to usual care in type 2 diabetes
mellitus patients with increased cardiovascular risk
RE: Notification of Safety letters
Dear Prof. Dr. dr.Rianto Setiabudi, SpFK
In accordance with Good Clinical Practice, I am pleased to submit the
following safety documents of the above mentioned study for your
notification. Please find enclosed the the CIOMS

Substance: BI 1356 + BI 10773

Manufacturer
Events
Report #
HYPERTRANSAMINASEMIA
2014-BI-45149BI(0) (Hypertransaminasaemia) [v.17.0] - Not
Yet Recovered

Date received by
Manufacturer
19-Sep-2014

Should you wish further information of any clarification, I am available at any

time to suit your convenience.
Thank you very much for your attention to this study.
Sincerely,
(________________________________)
dr.Wismandari Wisnu,SpPD-KEMD
Investigator
Please sign and date below to acknowledge your receipt of the above
mentioned study documents.
Name:
Signature:
Date: