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ID

30893

Description

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.

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Versions (1)
  1. 7/2/18 7/2/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 2, 2018

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Creative Commons BY-NC 3.0
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    Logs and Repeats (Logs/Rpts) Pazopanib Macular Degeneration MD1103367

    English

    Logs and Repeats (Logs/Rpts)

    1 forms  
    DATE OF VISIT/ASSESSMENT
    Description

    DATE OF VISIT/ASSESSMENT

    Alias
    UMLS CUI-1
    C1320303
    Date of visit/assessment
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    ADVERSE EVENT/CONCOMITANT MEDICATION/REPEAT ASSESSMENT CHECK QUESTIONS
    Description

    ADVERSE EVENT/CONCOMITANT MEDICATION/REPEAT ASSESSMENT CHECK QUESTIONS

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-3
    C2347852
    UMLS CUI-5
    C0681799
    Were any concomitant medications taken by the subject during the study?
    Description

    concomitant medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    Did the subject experience any adverse events during the study?
    Description

    adverse events

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248
    Were any repeat haematology or clinical chemistry samples taken?
    Description

    hematology; clinical chemistry

    Data type

    text

    Alias
    UMLS CUI [1]
    C0474523
    UMLS CUI [2]
    C0008000
    Were any repeat urinalysis sample taken?
    Description

    urinalysis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042014
    Were any repeat ECGs performed?
    Description

    ECG

    Data type

    text

    Alias
    UMLS CUI [1]
    C1623258
    Were any repeat vital signs recorded?
    Description

    vital signs

    Data type

    text

    Alias
    UMLS CUI [1]
    C0518766
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    Similar models

    Logs and Repeats (Logs/Rpts)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    undefined item
    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])
    undefined item
    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])
    undefined item
    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])
    undefined item
    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])
    undefined item
    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])
    undefined item
    Code List
    Were any repeat vital signs recorded?
    CL Item
    Yes (Y)
    CL Item
    No (N)
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