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ID

34380

Descrição

Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive.

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Versões (1)
  1. 17/01/2019 17/01/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

17 de janeiro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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    Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)

    Inglês

    End of Study Record

    1 Formulários  
    1. StudyEvent: ODM
      1. End of Study Record
    Administrative data
    Descrição

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Descrição

    Subject number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Status of treatment blind
    Descrição

    Status of treatment blind

    Alias
    UMLS CUI-1
    C0749659
    UMLS CUI-2
    C2347038
    Was the treatment blind for this subject broken during the study?
    Descrição

    If YES, complete the following.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3897431
    Date of subject unblinding event
    Descrição

    Date of subject unblinding event

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    Time of subject unblinding event
    Descrição

    Time of subject unblinding event

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0040223
    Reason of subject unblinding event
    Descrição

    Reason of subject unblinding event

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0566251
    If answer 'Other' was choosen as reason for subject unblinding event, specify:
    Descrição

    Specify 'Other' reason for subject unblinding event

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0205394
    End of Study Record
    Descrição

    End of Study Record

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C0444930
    Date of subject completion or discontinuation from the study
    Descrição

    Date of subject completion or discontinuation from the study

    Tipo de dados

    date

    Unidades de medida
    • dd.mm.yyyy
    Alias
    UMLS CUI [1,1]
    C2348577
    UMLS CUI [1,2]
    C0011008
    dd.mm.yyyy
    Time of subject completion or discontinuation from the study
    Descrição

    Time of subject completion or discontinuation from the study

    Tipo de dados

    time

    Unidades de medida
    • hh:mm
    Alias
    UMLS CUI [1,1]
    C2348577
    UMLS CUI [1,2]
    C0040223
    hh:mm
    Did the subject discontinue the study prematurely?
    Descrição

    premature discontinuation of study

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2348577
    UMLS CUI [1,2]
    C1279919
    If 'Yes', the primary reason for discontinuation:
    Descrição

    Record details on NON-SERIOUS ADVERSE EVENTS or SERIOUS ADVERSE EVENT page as appropriate.

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C2348577
    UMLS CUI [1,3]
    C1279919
    If 'Other', please specify:
    Descrição

    Specification reason for discontinuation

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2348235
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C2348577
    UMLS CUI [1,4]
    C1279919
    Investigator Comment Log
    Descrição

    Investigator Comment Log

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C0947611
    Date of comment
    Descrição

    Date of comment

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0011008
    CRF page number if applicable
    Descrição

    CRF page number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C1516308
    Comment
    Descrição

    Comment

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C0947611
    Investigator's statement: I confirm that I have carefully examined all entries on the Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
    Descrição

    Investigator's statement: I confirm that I have carefully examined all entries on the Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.

    Alias
    UMLS CUI-1
    C1516308
    UMLS CUI-2
    C1955348
    UMLS CUI-3
    C4288115
    UMLS CUI-4
    C2349182
    Date of Investigator's signature
    Descrição

    Date of Investigator's signature

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Investigator's signature
    Descrição

    Investigator's signature

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator's name - print
    Descrição

    Investigator's name - print

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826892
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    End of Study Record

    1 Formulários
    1. StudyEvent: ODM
      1. End of Study Record
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Status of treatment blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    Was the treatment blind for this subject broken during the study?
    Item
    Was the treatment blind for this subject broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    Date of subject unblinding event
    Item
    Date of subject unblinding event
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of subject unblinding event
    Item
    Time of subject unblinding event
    time
    C3897431 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Reason of subject unblinding event
    integer
    C3897431 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Reason of subject unblinding event
    Code List
    Reason of subject unblinding event
    CL Item
    Medical emergency requiring identity of investigational product for further treatment  (1)
    CL Item
    Other (2)
    Specify 'Other' reason for subject unblinding event
    Item
    If answer 'Other' was choosen as reason for subject unblinding event, specify:
    text
    C3897431 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item Group
    End of Study Record
    C0008976 (UMLS CUI-1)
    C0444930 (UMLS CUI-2)
    Date of subject completion or discontinuation from the study
    Item
    Date of subject completion or discontinuation from the study
    date
    C2348577 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of subject completion or discontinuation from the study
    Item
    Time of subject completion or discontinuation from the study
    time
    C2348577 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    premature discontinuation of study
    Item
    Did the subject discontinue the study prematurely?
    boolean
    C2348577 (UMLS CUI [1,1])
    C1279919 (UMLS CUI [1,2])
    Item
    If 'Yes', the primary reason for discontinuation:
    integer
    C0566251 (UMLS CUI [1,1])
    C2348577 (UMLS CUI [1,2])
    C1279919 (UMLS CUI [1,3])
    Reason for premature discontinuation
    Code List
    If 'Yes', the primary reason for discontinuation:
    CL Item
    Adverse event (1)
    CL Item
    Consent withdrawn (2)
    CL Item
    Lost to follow up (3)
    CL Item
    Protocol violation (4)
    CL Item
    Other (please specify below) (5)
    Specification reason for discontinuation
    Item
    If 'Other', please specify:
    text
    C2348235 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C2348577 (UMLS CUI [1,3])
    C1279919 (UMLS CUI [1,4])
    Item Group
    Investigator Comment Log
    C0008961 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    Date of comment
    Item
    Date of comment
    date
    C0947611 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    CRF page number
    Item
    CRF page number if applicable
    integer
    C1704732 (UMLS CUI [1,1])
    C1516308 (UMLS CUI [1,2])
    Comment
    Item
    Comment
    text
    C0008961 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Investigator's statement: I confirm that I have carefully examined all entries on the Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
    C1516308 (UMLS CUI-1)
    C1955348 (UMLS CUI-2)
    C4288115 (UMLS CUI-3)
    C2349182 (UMLS CUI-4)
    Date of Investigator's signature
    Item
    Date of Investigator's signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Investigator's name - print
    Item
    Investigator's name - print
    text
    C2826892 (UMLS CUI [1])
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