0 Bedömningar
ID

21498

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-04-25 2017-04-25 -
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25 april 2017

DOI

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Creative Commons BY-NC 3.0
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    Genetic Screening For HLA-B*5701 in Patients with HIV Concomitant Medications NCT00340080

    Engelsk

    Genetic Screening For HLA-B*5701 Concomitant Medications NCT00340080

    1 Formulär  
    Concomitant Medications
    Beskrivning

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Were any concomitant medications taken by the subject at screening or during the study?
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    Drug Name
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
    Start Date
    Beskrivning

    Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070 (Start Date)
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
    Taken Prior to Study?
    Beskrivning

    Taken Prior to Study

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2826667 (Concomitant Medication Previous Occurrence)
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
    Stop Date
    Beskrivning

    Stop Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
    Ongoing Medication?
    Beskrivning

    Ongoing Medication

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
    Concomitant Antiretroviral Therapy
    Beskrivning

    Concomitant Antiretroviral Therapy

    Alias
    UMLS CUI-1
    C1963724 (Antiretroviral therapy)
    LOINC
    LP66375-4
    UMLS CUI-2
    C2347852 (Concomitant Agent)
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Is this subject receiving antiretroviral therapy (ART) other than the ABC-Containing product(s) during the study?
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1963724 (Antiretroviral therapy)
    LOINC
    LP66375-4
    Drug Name
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    UMLS CUI [1,2]
    C1963724 (Antiretroviral therapy)
    LOINC
    LP66375-4
    Unit Dose
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0869039 (Unit dose)
    SNOMED
    408102007
    UMLS CUI [1,2]
    C1963724 (Antiretroviral therapy)
    LOINC
    LP66375-4
    Unit
    Beskrivning

    Unit

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    UMLS CUI [1,2]
    C1963724 (Antiretroviral therapy)
    LOINC
    LP66375-4
    Frequency
    Beskrivning

    Frequency

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3476109 (Medication frequency)
    LOINC
    LP149758-7
    UMLS CUI [1,2]
    C1963724 (Antiretroviral therapy)
    LOINC
    LP66375-4
    Start Date
    Beskrivning

    Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070 (Start Date)
    UMLS CUI [1,2]
    C1963724 (Antiretroviral therapy)
    LOINC
    LP66375-4
    Stop Date
    Beskrivning

    Stop Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    UMLS CUI [1,2]
    C1963724 (Antiretroviral therapy)
    LOINC
    LP66375-4
    Ongoing Medication?
    Beskrivning

    Ongoing Medication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2826666 (Concomitant Medication Ongoing)
    UMLS CUI [1,2]
    C1963724 (Antiretroviral therapy)
    LOINC
    LP66375-4
    Tillbaka till toppen

    Similar models

    Genetic Screening For HLA-B*5701 Concomitant Medications NCT00340080

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    antiretroviral therapy
    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])
    antiretroviral therapy
    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])
    antiretroviral therapy
    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])
    antiretroviral therapy
    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])
    Unit
    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])
    Frequency
    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])
    antiretroviral therapy
    Code List
    Ongoing Medication?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Tillbaka till toppen 

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