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  • No:XXX XX Mei 2013: Safety Letters Indonesia Blinded As Per 9 October 2014

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    This letter is clarifying notification of safety letters from March 2014 to October 2014 regarding a clinical trial of substance BI 10773. It references 8 safety letters reporting various adverse events, including 4 cases of pneumonia with acute respiratory distress syndrome that were fatal, 1 case of acute myocardial infarction that was fatal, and other non-fatal events like syncope, benign prostatic hyperplasia, and dyspepsia. The letter provides the principal investigator's contact information and requests confirmation of receipt of the attached safety letters and documents.

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    Cover Letter_ Clarification CIOMSreporting to EC Indonesian SAE March-Oct 2014 + PD Log_1245.25_62002_13 Oct 2014

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    This letter is clarifying notification of safety letters from March 2014 to October 2014 regarding a clinical trial of substance BI 10773. It references 8 safety letters reporting various adverse events, including 4 cases of pneumonia with acute respiratory distress syndrome that were fatal, 1 case of acute myocardial infarction that was fatal, and other non-fatal events like syncope, benign prostatic hyperplasia, and dyspepsia. The letter provides the principal investigator's contact information and requests confirmation of receipt of the attached safety letters and documents.

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    11 views2 pages

    No:XXX XX Mei 2013: Safety Letters Indonesia Blinded As Per 9 October 2014

    Uploaded by

    scribd
    This letter is clarifying notification of safety letters from March 2014 to October 2014 regarding a clinical trial of substance BI 10773. It references 8 safety letters reporting various adverse events, including 4 cases of pneumonia with acute respiratory distress syndrome that were fatal, 1 case of acute myocardial infarction that was fatal, and other non-fatal events like syncope, benign prostatic hyperplasia, and dyspepsia. The letter provides the principal investigator's contact information and requests confirmation of receipt of the attached safety letters and documents.

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    of 2

    PLEASE PRINT IN LETTERHEAD

    No:XXX
    XX Mei 2013

    Kepada Yth:
    Prof. Dr. dr. Rianto Setiabudi, SpFK
    Ketua Komite Etik, Fakultas Kedokteran, Universitas Indonesia
    Jalan Salemba Raya no. 6
    Jakarta, 10430 Indonesia.
    Judul Protokol: 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
    Nomor Protokol.: 1245.25
    Hal: Klarifikasi Notifikasi Safety Letters (Indonesia late Case March
    2014-October 2014)
    Yth. Prof Rianto
    Sehubungan dengan surat kami yang bernomor: 204/PT.02/FK.25/U.eu
    165/MET-END/X/2014 Tentang pelaporan CIOMs (Safety Letters Indonesia
    Blinded as of 9 October 2014)kami mengklarifikasikan bahwa CIOMs yang
    kami kirimkan adalah dari period Maret 2014 sampai dengan Oktober 2014.
    Adapun sebagai referensi surat yang kirimkan adalah sebagai berikut:
    Safety Letters Indonesia Blinded as per 9 October 2014:
    Substance: BI 10773
    Manufacturer Report #

    2013-BI-08140BI(6)

    2013-BI-10691BI(5)

    Events
    PNEUMONIA [WITH ARDS] (Pneumonia) [v.17.0] - Fatal
    [PNEUMONIA WITH] ARDS (Acute respiratory distress syndrome) [v.17.0] Fatal
    ACUTE LUNG OEDEM (Acute pulmonary oedema) [v.17.0] - Fatal
    SEPTIC SHOCK (Septic shock) [v.17.0] - Fatal
    ACUTE MI (Acute myocardial infarction) [v.17.0] - Fatal
    HEMATEMESIS EC STRESS ULCERS (Stress ulcer) [v.17.0] - Unknown
    ACUTE HYPERGLYCEMIA ON DM TYPE II (Hyperglycaemia) [v.17.0] Unknown
    Case level outcome :Fatal
    RECURRENT SYNCOPE (Syncope) [v.17.0] - Recovered
    BENIGN PROSTAT HYPERTROPHY (Benign prostatic hyperplasia) [v.17.0]
    Recovered Case level outcome :Recovered

    2013-BI-44175BI(3)

    DYSPEPSIA SYNDROME (Dyspepsia) [v.17.0] - Recovered


    Case level outcome :Recovered

    2013-BI-44175BI(2)

    DYSPEPSIA SYNDROME (Dyspepsia) [v.17.0] - Not Yet Recovered


    Case level outcome :Not Yet Recovered

    2014-BI-33737BI(0)

    VIRAL INFECTION (Viral infection) [v.17.0] - Recovered


    Case level outcome :Recovered
    Page 1 of 2

    Dengan ini pula kami mengirimkan update bahasa yang merefleksikan


    periode CIOMS tersebut berdasarkan surat kami yang bernomor:
    206/PT.02/FK.25/U.eu 167/MET-END/X/2014
    Terima kasih atas perhatiannya jika ada pertanyaan silakan menghubungi
    saya.
    Salam,

    dr. Dante Saksono Harbuwono, SpPD-KEMD, PhD.


    Principal Investigator
    Saya yang bertandatangan di bawah ini telah menerima surat dan dokumen terlampir:
    Nama:

    Tanda tangan:

    Tanggal:

    Page 2 of 2

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