0 Beoordelingen
ID

33060

Beschrijving

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

Trefwoorden

Versies (1)
  1. 26-11-18 26-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

26 november 2018

DOI

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Licentie

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

    Engels

    Rash / Exanthem AE Form

    1 Formulieren  
    Administrative data
    Beschrijving

    Administrative data

    Subject Number
    Beschrijving

    Subject Number

    Datatype

    integer

    Rash/Exanthem
    Beschrijving

    Rash/Exanthem

    Event Number
    Beschrijving

    Please report any rash event that occurred during the study period

    Datatype

    integer

    Description
    Beschrijving

    Description

    Datatype

    text

    Administration sites
    Beschrijving

    Administration sites

    Datatype

    text

    Non-administration site
    Beschrijving

    Non-administration site

    Datatype

    text

    Further Event Details (For GSK)
    Beschrijving

    Further Event Details (For GSK)

    Event Number
    Beschrijving

    Event Number

    Datatype

    integer

    Category
    Beschrijving

    Category

    Datatype

    text

    If Other, specify
    Beschrijving

    If Other, specify

    Datatype

    text

    Date started
    Beschrijving

    Date started

    Datatype

    date

    Date stopped
    Beschrijving

    Date stopped

    Datatype

    date

    Intensity
    Beschrijving

    Intensity

    Datatype

    text

    Has a vesicular fluid sample been taken?
    Beschrijving

    Has a vesicular fluid sample been taken?

    Datatype

    boolean

    If Yes, record date
    Beschrijving

    If Yes, record date

    Datatype

    date

    Relationship to investigational products
    Beschrijving

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

    Datatype

    boolean

    Outcome
    Beschrijving

    Outcome

    Datatype

    text

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    Similar models

    Rash / Exanthem AE Form

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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