PLEASE PRINT THE LETTER IN AN INSTITUTION LETTER HEAD

Jakarta, 14
November 2014
No. of Letter: <Departments reference number for correspondence>
To:
Prof. Dr. dr. Rianto Setiabudi, SpFK
The Chairman of The Committee of The Medical Research ethics of the 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 Suspected Serious Adverse Reaction (SUSAR) Report and Blinded
Listing that occurred in the protocol referred above :
1. Quarterly SUSAR Report No. S00026565-01, date
report period: 01 Jul 2014 until 30 Sep 2014. Test
2. Quarterly SUSAR Report No. S00026573-01, date
report period: 01 Jul 2014 until 30 Sep 2014. Test
(BI10773) and Linagliptin (Bl 1356)
3. Quarterly SUSAR Report No. S00026685-01, date
report period: 01 Jul 2014 until 30 Sep 2014. Test
(BI10773) and Metformin

of report: 16 Oct 2014,

Substance : Empagliflozin
of report: 22 Oct 2014,
Substance : Empagliflozin
of report: 16 Oct 2014,
Substance : Empagliflozin

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. Dante Saksono Harbuwono, SpPD-KEMD, PhD.

Principal Investigator
Please sign and date below to acknowledge your receipt of the above mentioned
study documents.
Name:
Signature:
Date: