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    Workshop 2. Pelaporan AE & SAE - DR Henu Tonang

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    Ajiss Mahri
    1. A 45-year-old male participating in a phase III clinical trial for a diabetes drug reported adverse events. 2. On August 24, he reported mild muscle pain in both arms for 2 days 5 days prior that resolved with topical medication. 3. On September 28, he was hospitalized for low blood sugar (30 mg/dl) and lost consciousness for a day, requiring IV fluids before discharge. The study drug was stopped during hospitalization.

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    Workshop 2. Pelaporan AE & SAE - DR Henu Tonang

    Uploaded by

    Ajiss Mahri
    27 views3 pages
    1. A 45-year-old male participating in a phase III clinical trial for a diabetes drug reported adverse events. 2. On August 24, he reported mild muscle pain in both arms for 2 days 5 days prior that resolved with topical medication. 3. On September 28, he was hospitalized for low blood sugar (30 mg/dl) and lost consciousness for a day, requiring IV fluids before discharge. The study drug was stopped during hospitalization.

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    Workshop 2. Pelaporan AE & SAE - Dr Henu Tonang

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    1. A 45-year-old male participating in a phase III clinical trial for a diabetes drug reported adverse events. 2. On August 24, he reported mild muscle pain in both arms for 2 days 5 days prior that resolved with topical medication. 3. On September 28, he was hospitalized for low blood sugar (30 mg/dl) and lost consciousness for a day, requiring IV fluids before discharge. The study drug was stopped during hospitalization.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    27 views3 pages

    Workshop 2. Pelaporan AE & SAE - DR Henu Tonang

    Uploaded by

    Ajiss Mahri
    1. A 45-year-old male participating in a phase III clinical trial for a diabetes drug reported adverse events. 2. On August 24, he reported mild muscle pain in both arms for 2 days 5 days prior that resolved with topical medication. 3. On September 28, he was hospitalized for low blood sugar (30 mg/dl) and lost consciousness for a day, requiring IV fluids before discharge. The study drug was stopped during hospitalization.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 3

    Workshop 2

    Pelaporan AE/SAE
    Site No: 201

    Subjek ID: 120

    Subjek Initial: CBD

    Subjek Sex : Pria

    Subjek Usia : 45 tahun

    Subjek sedang mengikuti Uji klinik fase III obat diabetes. Obat Uji diberikan 2 kali
    sehari. Subjek partisipasi dalam uji klinik ini sejak 27 Jul. 2021.

    Pada visit tgl 24 Aug. 2021, Subjek mengeluh bahwa 5 hari yang lalu mengalami
    nyeri otot di kedua lengan (myalgia) sedang, nyeri otot berlangsung selama 2
    hari. Keluhan nyeri otot menghilang setelah diberikan obat gosok. Obat uji tetap
    dikonsumsi sesuai anjuran yaitu 2 kali sehari. Kejadian seperti ini belum pernah
    dilaporkan dalam penelitian sebelumnya.

    Pada Vist tgl 28 Sep. 2021, Subjek menginformasikan bahwa 6 hari yang lalu
    dibawa ke Rumah Sakit karena tidak sadarkan diri, subjek dirawat di Rumah sakit
    dengan diagnose kadar gula rendah 30 mg/dl (hipoglikemi), Subjek sadar kembali
    setelah diberikan infus, subjek dipulangkan setelah dirawat 1 malam. Selama di
    rawat di RS, obat uji dihentikan pemberiannya. Kejadian seperti ini pernah
    dilaporkan dalam penelitian sebelumnya.

    Ver 2021-9-8 – Virtual


    Adverse Event Form
    STUDY NAME

    Subject ID : __________ Subject Initial :


    Site Number: ______________________

    Has the participant had any Adverse Events during this study? Yes No (If yes, please list all Adverse Events below)
    Severity Study Intervention Action Taken Regarding Study Outcome of AE Expected Serious
    Relationship Intervention
    1 = Mild 1 = Definitely related 1 = None 1 = Resolved, No Sequel 1 = Yes 1 = Yes
    2 = Moderate 2 = Probable related 2 = Discontinued permanently 2 = AE still present- no treatment 2 = No 2 = No
    3 = Severe 3 = Possibly related 3 = Discontinued temporarily 3 = AE still present-being treated (If yes,
    4 = Life threatening 4 = Reduced Dose 4 = Residual effects present-not treated complete SAE
    4 = Unlikely related
    5 = Death 5 = Increased Dose 5 = Residual effects present- treated form)
    5 = Unrelated 6 = Delayed Dose 6 = Death
    7 = Unknown

    Adverse Event Start Date Stop Date Severity Relationship to Action Outcome Expected? Serious Initials
    Study Treatment Taken of AE Adverse
    Event?

    1.

    2.

    3.

    Adverse Event Form Version 4.0 _2017-08


    Serious Adverse Event Form

    Protocol Title:

    Protocol number:

    Site Number: _________ Subject ID: ________ Subject Initial

    1. SAE Onset Date: _____________________ 2. SAE Stop Date: _____________________


    (dd/mmm/yyyy) (dd/mmm/yyyy)

    3. Was this an expected adverse event? Yes No

    4. Brief description of participant with no personal identifiers:

    Sex: Female Male Age: __________ yrs


    5. Brief description of the nature of the serious adverse event

    6. Category of the SAE:


    death – date __________ (dd/mmm/yyyy) disability / incapacity
    life-threatening congenital anomaly / birth defect
    hospitalization - initial or prolonged other:

    7. Relationship of event to intervention: Definite (clearly related to intervention)


    Probable (reasonable related to intervention)
    Possible (may be related to intervention or others)
    Unlikely (temporal relationship improbable)
    Unrelated (clearly not related to the intervention)

    1. 8. Was study intervention discontinued due to event? Yes No

    9. What medications or other steps were taken to treat serious adverse event?

    10. List any relevant tests, laboratory data, history, including preexisting medical conditions

    11. Type of Report : Initial Follow-up Final

    12. Signature of Principal Investigator: ______________________________ Date: __________________

    3Serious Adverse Event Report Form 1 of 1 Ver 4.0_2017-08

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