0 Evaluaciones
ID

43930

Descripción

Visit 1 Laboratory Tests Screening form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Palabras clave

Versiones (2)
  1. 30/7/17 30/7/17 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Visit 1 Laboratory Tests Biologicals HepA/HepB vaccine 208127/125

    Inglés

    Visit 1 Laboratory Tests Biologicals HepA/HepB vaccine 208127/125

    1 formularios  
    Header
    Descripción

    Header

    Alias
    UMLS CUI-1
    C1320722
    Protocol
    Descripción

    Protocol

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1507394
    Activity
    Descripción

    Activity

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1512346
    Date of activity
    Descripción

    day/month/year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject number
    Descripción

    Subject number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Laboratory tests - Screening
    Descripción

    Laboratory tests - Screening

    Alias
    UMLS CUI-1
    C0022885
    Has blood sample been taken ?
    Descripción

    if yes, enter all results or attach individual laboratory report behind this page

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    Date of blood sampling :
    Descripción

    day/month/year

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0178913
    UMLS CUI [1,2]
    C0011008
    Please comment :
    Descripción

    blood sample has not been taken

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0005834
    Biochemistry
    Descripción

    Biochemistry

    Alias
    UMLS CUI-1
    C0005477
    result of the ALT measurement
    Descripción

    ND = not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0201836
    abnormalities of the ALT measurement
    Descripción

    if the result is outside the normal range, please repeat the blood sample

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0201836
    results of the AST measurement
    Descripción

    ND = not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0201899
    abnormalities of the AST measurement
    Descripción

    if the result is outside the normal range, please repeat the blood sample

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0201899
    Serology
    Descripción

    Serology

    Alias
    UMLS CUI-1
    C0036743
    result of the anti-HAV measurement
    Descripción

    ND = not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0062524
    result of the anti-HBs measurement
    Descripción

    ND = not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0201478
    result of the anti-HBc measurement
    Descripción

    ND = not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0312631
    result of the HBsAg measurement
    Descripción

    ND = not done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0019168
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Comments, if any
    Descripción

    Comments

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611
    Date :
    Descripción

    day/month/year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0011008
    Investigator Signature :
    Descripción

    Signature

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2346576
    Volver a la parte superior de la página

    Similar models

    Visit 1 Laboratory Tests Biologicals HepA/HepB vaccine 208127/125

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Header
    C1320722 (UMLS CUI-1)
    Protocol
    Item
    Protocol
    text
    C1507394 (UMLS CUI [1])
    Activity
    Item
    Activity
    text
    C1512346 (UMLS CUI [1])
    Date of activity
    Item
    Date of activity
    date
    C1320303 (UMLS CUI [1])
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Laboratory tests - Screening
    C0022885 (UMLS CUI-1)
    Blood sample
    Item
    Has blood sample been taken ?
    boolean
    C0005834 (UMLS CUI [1])
    Date of blood sampling
    Item
    Date of blood sampling :
    date
    C0178913 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    No blood sample taken
    Item
    Please comment :
    text
    C0005834 (UMLS CUI [1])
    Item Group
    Biochemistry
    C0005477 (UMLS CUI-1)
    ALT measurement result
    Item
    result of the ALT measurement
    integer
    C0201836 (UMLS CUI [1])
    Item
    abnormalities of the ALT measurement
    integer
    C1704258 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    ALT measurement abnormalities
    Code List
    abnormalities of the ALT measurement
    CL Item
    laboratory error (1)
    CL Item
    preexisting/concomitant medical condition (2)
    CL Item
    prior/concomitant medication (3)
    CL Item
    unknown (4)
    Item
    results of the AST measurement
    integer
    C0201899 (UMLS CUI [1])
    AST measurement
    Code List
    results of the AST measurement
    Item
    abnormalities of the AST measurement
    integer
    C1704258 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    AST measurement abnormalities
    Code List
    abnormalities of the AST measurement
    CL Item
    laboratory error (1)
    CL Item
    preexisting/concomitant medical condition (2)
    CL Item
    prior/concomitant medication (3)
    CL Item
    unknown (4)
    Item Group
    Serology
    C0036743 (UMLS CUI-1)
    anti-HAV measurement result
    Item
    result of the anti-HAV measurement
    integer
    C0062524 (UMLS CUI [1])
    anti-HBs measurement result
    Item
    result of the anti-HBs measurement
    integer
    C0201478 (UMLS CUI [1])
    Item
    result of the anti-HBc measurement
    integer
    C0312631 (UMLS CUI [1])
    anti-HBc measurement
    Code List
    result of the anti-HBc measurement
    HBsAg measurement result
    Item
    result of the HBsAg measurement
    integer
    C0019168 (UMLS CUI [1])
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Comments
    Item
    Comments, if any
    text
    C0947611 (UMLS CUI [1])
    Date
    Item
    Date :
    date
    C0011008 (UMLS CUI [1])
    Signature
    Item
    Investigator Signature :
    text
    C2346576 (UMLS CUI [1])
    Volver a la parte superior de la página 

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