ID

21498

Description

NCT00340080 / VIIV-CNA106030 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Concomitant Medications Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

Keywords

  1. 4/25/17 4/25/17 -
Uploaded on

April 25, 2017

DOI

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License

Creative Commons BY-NC 3.0

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    Genetic Screening For HLA-B*5701 in Patients with HIV Concomitant Medications NCT00340080

    Genetic Screening For HLA-B*5701 Concomitant Medications NCT00340080

    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Were any concomitant medications taken by the subject at screening or during the study?
    Description

    If Yes, record each medication on a separate line using Trade Names where possible.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    Drug Name
    Description

    If Yes, record each medication on a separate line using Trade Names where possible.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C2347852
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C2347852
    Taken Prior to Study?
    Description

    Taken Prior to Study

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826667
    UMLS CUI [1,2]
    C2347852
    Stop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C2347852
    Ongoing Medication?
    Description

    Ongoing Medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826666
    Concomitant Antiretroviral Therapy
    Description

    Concomitant Antiretroviral Therapy

    Alias
    UMLS CUI-1
    C1963724
    UMLS CUI-2
    C2347852
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Is this subject receiving antiretroviral therapy (ART) other than the ABC-Containing product(s) during the study?
    Description

    If Yes, record each medication on a separate line using Trade Names where possible.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1963724
    Drug Name
    Description

    If Yes, record each medication on a separate line using Trade Names where possible.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C1963724
    Unit Dose
    Description

    If Yes, record each medication on a separate line using Trade Names where possible

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0869039
    UMLS CUI [1,2]
    C1963724
    Unit
    Description

    Unit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C1963724
    Frequency
    Description

    Frequency

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3476109
    UMLS CUI [1,2]
    C1963724
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1963724
    Stop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1963724
    Ongoing Medication?
    Description

    Ongoing Medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826666
    UMLS CUI [1,2]
    C1963724

    Similar models

    Genetic Screening For HLA-B*5701 Concomitant Medications NCT00340080

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item
    Were any concomitant medications taken by the subject at screening or during the study?
    text
    C2347852 (UMLS CUI [1])
    Code List
    Were any concomitant medications taken by the subject at screening or during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item
    Taken Prior to Study?
    text
    C2826667 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Code List
    Taken Prior to Study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item
    Ongoing Medication?
    text
    C2826666 (UMLS CUI [1])
    Code List
    Ongoing Medication?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Concomitant Antiretroviral Therapy
    C1963724 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item
    Is this subject receiving antiretroviral therapy (ART) other than the ABC-Containing product(s) during the study?
    text
    C1963724 (UMLS CUI [1])
    Code List
    Is this subject receiving antiretroviral therapy (ART) other than the ABC-Containing product(s) during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1,1])
    C1963724 (UMLS CUI [1,2])
    Unit Dose
    Item
    Unit Dose
    text
    C0869039 (UMLS CUI [1,1])
    C1963724 (UMLS CUI [1,2])
    Item
    Unit
    text
    C1519795 (UMLS CUI [1,1])
    C1963724 (UMLS CUI [1,2])
    Code List
    Unit
    CL Item
    Tablet  (TAB)
    CL Item
    Microlitre  (MCL)
    CL Item
    Millilitre  (ML)
    CL Item
    Litre  (L)
    CL Item
    Microgram  (MCG)
    CL Item
    Milligram  (MG)
    CL Item
    Gram (G)
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1,1])
    C1963724 (UMLS CUI [1,2])
    Code List
    Frequency
    CL Item
    1 x Daily (OD)
    CL Item
    2 x Daily (BID)
    CL Item
    3 x Daily (TID)
    CL Item
    4 x Daily  (QID)
    CL Item
    As required (PRN)
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C1963724 (UMLS CUI [1,2])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1,1])
    C1963724 (UMLS CUI [1,2])
    Item
    Ongoing Medication?
    text
    C2826666 (UMLS CUI [1,1])
    C1963724 (UMLS CUI [1,2])
    Code List
    Ongoing Medication?
    CL Item
    Yes (Y)
    CL Item
    No (N)

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