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  • TENALEA - UMBRELLA - Sae (F8) - 72418002

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    A study participant experienced a febrile upper respiratory infection caused by Paraionfluenza 3 virus that required hospitalization from June 8-10, 2021. The event was classified as an unplanned hospitalization and deemed possibly related to the study treatment. The infection was determined to be a grade 2 toxicity according to CTCAE standards.

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    Protocolo Alea tumores renales

    Original Title

    TENALEA_UMBRELLA_Sae (F8)_72418002

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    A study participant experienced a febrile upper respiratory infection caused by Paraionfluenza 3 virus that required hospitalization from June 8-10, 2021. The event was classified as an unplanned hospitalization and deemed possibly related to the study treatment. The infection was determined to be a grade 2 toxicity according to CTCAE standards.

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    © All Rights Reserved
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    8 views1 page

    TENALEA - UMBRELLA - Sae (F8) - 72418002

    Uploaded by

    mg
    A study participant experienced a febrile upper respiratory infection caused by Paraionfluenza 3 virus that required hospitalization from June 8-10, 2021. The event was classified as an unplanned hospitalization and deemed possibly related to the study treatment. The infection was determined to be a grade 2 toxicity according to CTCAE standards.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 1

    Notification for study UMBRELLA

    Sae (F8)
    Form completed by : Guibelalde
    Form completion date: 11 Jun 2021 at 13:38:38
    Clinician: Guibelalde
    Institute: Hospital Universitari Son Espases
    1 Event description: Other, specify
    2 Specify other febrile upper respiratory infection
    3 Please comment briefly on nature of SAE Infection Paraionfluenza 3 virus
    4 Toxicity grade according CTCAE 2
    5 Classification Unplanned Hospitalisation (or prolongation of planned
    hospitalisation)
    6 Start date 08 Jun 2021
    7 Ongoing No
    8 Stop date 10 Jun 2021
    9 Could the patient's original condition or other illness Probably
    account for this event?
    10 Do you think the event was related to the treatment? Possibly

    Patient has been assigned patient number: 72418002

    Randomization service provided by TENALEA - www.tenalea.com

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