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ID

33060

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Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella CRF Seiten: 268-336; 870-938

Nyckelord

Versioner (1)
  1. 2018-11-26 2018-11-26 -
Rättsinnehavare

GSK group of companies

Uppladdad den

26 november 2018

DOI

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Creative Commons BY-NC 3.0
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    Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

    Engelsk

    Rash / Exanthem AE Form

    1 Formulär  
    Administrative data
    Beskrivning

    Administrative data

    Subject Number
    Beskrivning

    Subject Number

    Datatyp

    integer

    Rash/Exanthem
    Beskrivning

    Rash/Exanthem

    Event Number
    Beskrivning

    Please report any rash event that occurred during the study period

    Datatyp

    integer

    Description
    Beskrivning

    Description

    Datatyp

    text

    Administration sites
    Beskrivning

    Administration sites

    Datatyp

    text

    Non-administration site
    Beskrivning

    Non-administration site

    Datatyp

    text

    Further Event Details (For GSK)
    Beskrivning

    Further Event Details (For GSK)

    Event Number
    Beskrivning

    Event Number

    Datatyp

    integer

    Category
    Beskrivning

    Category

    Datatyp

    text

    If Other, specify
    Beskrivning

    If Other, specify

    Datatyp

    text

    Date started
    Beskrivning

    Date started

    Datatyp

    date

    Date stopped
    Beskrivning

    Date stopped

    Datatyp

    date

    Intensity
    Beskrivning

    Intensity

    Datatyp

    text

    Has a vesicular fluid sample been taken?
    Beskrivning

    Has a vesicular fluid sample been taken?

    Datatyp

    boolean

    If Yes, record date
    Beskrivning

    If Yes, record date

    Datatyp

    date

    Relationship to investigational products
    Beskrivning

    is there a reasonable possibility that the AE may have been caused by the investigational product?

    Datatyp

    boolean

    Outcome
    Beskrivning

    Outcome

    Datatyp

    text

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    Similar models

    Rash / Exanthem AE Form

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    Subject Number
    Item
    Subject Number
    integer
    Item Group
    Rash/Exanthem
    Item
    Event Number
    integer
    Event Number
    Code List
    Event Number
    CL Item
    RA. 1 (1)
    CL Item
    RA. 2 (2)
    Description
    Item
    Description
    text
    Item
    Administration sites
    text
    Administration sites
    Code List
    Administration sites
    CL Item
    MemURu-OKA vaccine (1)
    CL Item
    Priorix vaccine (2)
    CL Item
    Varilirix vaccine (3)
    Item
    Non-administration site
    text
    Non-administration site
    Code List
    Non-administration site
    CL Item
    Generalized (1)
    CL Item
    Localized (2)
    Item Group
    Further Event Details (For GSK)
    Item
    Event Number
    integer
    Event Number
    Code List
    Event Number
    CL Item
    RA. 1 (1)
    CL Item
    RA. 2 (2)
    Item
    Category
    text
    Category
    Code List
    Category
    CL Item
    Varicella rash (1)
    CL Item
    Measles / rubella-rash (2)
    CL Item
    Other (3)
    If Other, specify
    Item
    If Other, specify
    text
    Date started
    Item
    Date started
    date
    Date stopped
    Item
    Date stopped
    date
    Item
    Intensity
    text
    Intensity
    Code List
    Intensity
    CL Item
    1 - 50 lesions (1)
    CL Item
    51 - 150 lesions (2)
    CL Item
    > 150 lesions (3)
    Has a vesicular fluid sample been taken?
    Item
    Has a vesicular fluid sample been taken?
    boolean
    If Yes, record date
    Item
    If Yes, record date
    date
    Relationship to investigational products
    Item
    Relationship to investigational products
    boolean
    Item
    Outcome
    text
    Outcome
    Code List
    Outcome
    CL Item
    Recovered/Resolved (1)
    CL Item
    Recovering/Resolving (2)
    CL Item
    Not recovered/Not resolved (3)
    CL Item
    Recovered with sequelae/Resolved with sequelae (4)
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