0 Ratings
ID

41157

Description

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

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Versions (1)
  1. 7/2/20 7/2/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 2, 2020

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Creative Commons BY-NC 4.0
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    Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

    English

    Physical Examination

    1 forms  
    1. StudyEvent: ODM
      1. Physical Examination
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Date of Assessment
    Description

    Date of Assessment

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Physical Examination
    Description

    Physical Examination

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Physical Examination Finding
    Description

    If ABNORMAL, describe concisely

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0243095 (Finding)
    LOINC
    LA9042-8
    Physical examination abnormal finding description
    Description

    Physical examination abnormal finding description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826636 (Physical Examination Abnormal Finding)
    UMLS CUI [1,2]
    C0678257 (Description)
    LOINC
    LP6800-9
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    Similar models

    Physical Examination

    1 forms
    1. StudyEvent: ODM
      1. Physical Examination
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Item
    Physical Examination
    integer
    C0031809 (UMLS CUI [1])
    Physical Examination
    Code List
    Physical Examination
    CL Item
    Hair and skin (1)
    CL Item
    Lymph nodes (2)
    CL Item
    Eyes (3)
    CL Item
    Ears, Nose, Throat (4)
    CL Item
    Breasts (5)
    CL Item
    Respiratory (6)
    CL Item
    Cardiovascular (7)
    CL Item
    Abdomen (8)
    CL Item
    Urogenital (9)
    CL Item
    Pelvic (10)
    CL Item
    Rectal (11)
    CL Item
    Musculoskeletal (12)
    CL Item
    Neurological (13)
    CL Item
    Mental Status (14)
    Item
    Physical Examination Finding
    integer
    C0031809 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    Physical Examination Finding
    Code List
    Physical Examination Finding
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not Done (3)
    Physical examination abnormal finding description
    Item
    Physical examination abnormal finding description
    text
    C2826636 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Back to the top of the page 

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