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BI - Cover Letter Template For EC Submission - Sent 09 Sept 2014
BI - Cover Letter Template For EC Submission - Sent 09 Sept 2014
Jakarta, 24
Oktober 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 10773
Manufacturer
Events
Report #
ANGIOMATOUS SKIN LESIONS
2014-BI-40144BI(0) BILATERAL BUTTOCKS (Skin
lesion) [v.17.0] - Not Yet Recovered
Date received by
Manufacturer
27-Aug-2014