0 Avaliações

ID

30893

Descrição

Study part: Logs and Repeats (Logs/Rpts). A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Palavras-chave

  1. 02/07/2018 02/07/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

2 de julho de 2018

DOI

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Licença

Creative Commons BY-NC 3.0

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    Logs and Repeats (Logs/Rpts) Pazopanib Macular Degeneration MD1103367

    Logs and Repeats (Logs/Rpts)

    DATE OF VISIT/ASSESSMENT
    Descrição

    DATE OF VISIT/ASSESSMENT

    Alias
    UMLS CUI-1
    C1320303 (Date of visit)
    SNOMED
    406543005
    Date of visit/assessment
    Descrição

    Date of visit

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    ADVERSE EVENT/CONCOMITANT MEDICATION/REPEAT ASSESSMENT CHECK QUESTIONS
    Descrição

    ADVERSE EVENT/CONCOMITANT MEDICATION/REPEAT ASSESSMENT CHECK QUESTIONS

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI-3
    C2347852 (Concomitant Agent)
    UMLS CUI-5
    C0681799 (research question)
    Were any concomitant medications taken by the subject during the study?
    Descrição

    concomitant medication

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    Did the subject experience any adverse events during the study?
    Descrição

    adverse events

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Were any repeat haematology or clinical chemistry samples taken?
    Descrição

    hematology; clinical chemistry

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0474523 (Hematology finding)
    SNOMED
    250207003
    UMLS CUI [2]
    C0008000 (Chemistry, Clinical)
    Were any repeat urinalysis sample taken?
    Descrição

    urinalysis

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    Were any repeat ECGs performed?
    Descrição

    ECG

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1623258 (Electrocardiography)
    SNOMED
    29303009
    LOINC
    LP6244-0
    Were any repeat vital signs recorded?
    Descrição

    vital signs

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7

    Similar models

    Logs and Repeats (Logs/Rpts)

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    DATE OF VISIT/ASSESSMENT
    C1320303 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1])
    Item Group
    ADVERSE EVENT/CONCOMITANT MEDICATION/REPEAT ASSESSMENT CHECK QUESTIONS
    C0877248 (UMLS CUI-1)
    C2347852 (UMLS CUI-3)
    C0681799 (UMLS CUI-5)
    Item
    Were any concomitant medications taken by the subject during the study?
    text
    C2347852 (UMLS CUI [1])
    Code List
    Were any concomitant medications taken by the subject during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Did the subject experience any adverse events during the study?
    text
    C0877248 (UMLS CUI [1])
    Code List
    Did the subject experience any adverse events during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any repeat haematology or clinical chemistry samples taken?
    text
    C0474523 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    Code List
    Were any repeat haematology or clinical chemistry samples taken?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any repeat urinalysis sample taken?
    text
    C0042014 (UMLS CUI [1])
    Code List
    Were any repeat urinalysis sample taken?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any repeat ECGs performed?
    text
    C1623258 (UMLS CUI [1])
    Code List
    Were any repeat ECGs performed?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any repeat vital signs recorded?
    text
    C0518766 (UMLS CUI [1])
    Code List
    Were any repeat vital signs recorded?
    CL Item
    Yes (Y)
    CL Item
    No (N)

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