0 Avaliações

ID

16057

Descrição

Documentation part: Log Status & Randomisation Number A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo. ClinicalTrials.gov Identifier: NCT00133874 Other Study ID Numbers: TOC100224 Responsible Party: GlaxoSmithKline

Palavras-chave

  1. 27/06/2016 27/06/2016 -
Transferido a

27 de junho de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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    Log Status & Randomisation Number Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

    Log Status & Randomisation Number Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

    Log Status
    Descrição

    Log Status

    Did the subject experience any adverse events during the study?
    Descrição

    Did the subject experience any adverse events during the study?

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0877248
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    Descrição

    Were any concomitant medications taken by the subject prior to screening and/or during the study?

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2347852
    Case book ready for signature
    Descrição

    CRA should check the box when data cleaning is complete. This item is used for Phase I trials only. Remove for Phase II-IV

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519316
    For inform only: Do not data enter
    Descrição

    For inform only: Do not data enter

    Q1
    Descrição

    Q1

    Tipo de dados

    text

    Q2
    Descrição

    Q2

    Tipo de dados

    text

    Randomisation Number (RAND)
    Descrição

    Randomisation Number (RAND)

    Randomisation number
    Descrição

    Randomisation number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0449788
    UMLS CUI [1,2]
    C0034656

    Similar models

    Log Status & Randomisation Number Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Log Status
    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
    No (N)
    CL Item
    Yes (Y)
    Item
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    text
    C2347852 (UMLS CUI [1])
    Code List
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Case book ready for signature
    text
    C1519316 (UMLS CUI [1])
    Code List
    Case book ready for signature
    CL Item
    Yes (Y)
    Item Group
    For inform only: Do not data enter
    Item
    Q1
    text
    Code List
    Q1
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Q2
    text
    Code List
    Q2
    CL Item
    PF_SC_LOST (1)
    CL Item
    PF_SC_DEATH (2)
    CL Item
    PF_SC_SPONSORDECISlON (3)
    CL Item
    PF_SC_PHYS[ClANDEClSlON (4)
    CL Item
    PF_SC_PATIENTDEClSION (5)
    CL Item
    PF_SC_AE (6)
    CL Item
    PF_SC_CRlTERIA (7)
    CL Item
    PF_SC_OTHER (8)
    Item Group
    Randomisation Number (RAND)
    Randomisation number
    Item
    Randomisation number
    integer
    C0449788 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])

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