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ID

14767

Description

NINDS Common Data Elements Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

Link

https://www.commondataelements.ninds.nih.gov/

Keywords

  1. 4/27/16 4/27/16 -
Uploaded on

April 27, 2016

DOI

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License

Creative Commons BY-NC 3.0

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    NINDS CDE Adverse Event Tracking Log Epilepsy

    Adverse Event Tracking Log

    Adverse Events
    Description

    Adverse Events

    Adverse Event
    Description

    (Please use medical terminology)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    AE Start date
    Description

    AE Start date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697888 (Adverse Event Start Date)
    AE End date
    Description

    AE End date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697886 (Adverse Event End Date)
    AE ongoing
    Description

    AE ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0549178 (Continuous)
    SNOMED
    255238004
    LOINC
    LA16902-1
    AE Severity
    Description

    AE Severity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2985921 (Adverse Event Severity Code)
    Relatedness
    Description

    AE causality

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3641099 (Study Treatment Causality)
    Action Taken with Study Intervention
    Description

    Action Taken

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826626 (Adverse Event Action Taken with Study Treatment)
    Action Taken with AED
    Description

    Action Taken

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0441472 (Clinical action)
    SNOMED
    129264002
    Outcome
    Description

    Outcome

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1705586 (Adverse Event Outcome)
    Serious Adverse Event
    Description

    SAE

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255 (Serious Adverse Event)

    Similar models

    Adverse Event Tracking Log

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Adverse Events
    Adverse Event
    Item
    Adverse Event
    text
    C0877248 (UMLS CUI [1])
    AE Start date
    Item
    AE Start date
    date
    C2697888 (UMLS CUI [1])
    AE End date
    Item
    AE End date
    date
    C2697886 (UMLS CUI [1])
    AE ongoing
    Item
    AE ongoing
    boolean
    C0877248 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Item
    AE Severity
    integer
    C2985921 (UMLS CUI [1])
    Code List
    AE Severity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Life-threatening/Disabling (4)
    CL Item
    Death (5)
    Item
    Relatedness
    integer
    C3641099 (UMLS CUI [1])
    Code List
    Relatedness
    CL Item
    Unrelated (1)
    CL Item
    Unlikely (2)
    CL Item
    Probable (3)
    CL Item
    Possible (4)
    CL Item
    Definite (5)
    Item
    Action Taken with Study Intervention
    integer
    C2826626 (UMLS CUI [1])
    Code List
    Action Taken with Study Intervention
    CL Item
    None (1)
    CL Item
    Study Intervention Interrupted (2)
    CL Item
    Study Intervention Discontinued (3)
    CL Item
    Study Intervention Modified (4)
    Item
    Action Taken with AED
    integer
    C0877248 (UMLS CUI [1,1])
    C0441472 (UMLS CUI [1,2])
    Code List
    Action Taken with AED
    CL Item
    None (1)
    CL Item
    AED therapy temporarily interrupted (2)
    CL Item
    AED therapy permanently stopped (3)
    CL Item
    AED therapy modified (4)
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1])
    Code List
    Outcome
    CL Item
    Recovered/Resolved (1)
    CL Item
    Recovered/Resolved With Sequelae (2)
    CL Item
    Recovering/Resolving (3)
    CL Item
    Not Recovered/Not Resolved (4)
    CL Item
    Fatal (5)
    CL Item
    Unknown (6)
    SAE
    Item
    Serious Adverse Event
    boolean
    C1519255 (UMLS CUI [1])

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