0 Ratings
ID

43930

Description

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

Keywords

Versions (2)
  1. 7/30/17 7/30/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

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

    English

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

    1 forms  
    Header
    Description

    Header

    Alias
    UMLS CUI-1
    C1320722
    Protocol
    Description

    Protocol

    Data type

    text

    Alias
    UMLS CUI [1]
    C1507394
    Activity
    Description

    Activity

    Data type

    text

    Alias
    UMLS CUI [1]
    C1512346
    Date of activity
    Description

    day/month/year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject number
    Description

    Subject number

    Data type

    text

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

    Laboratory tests - Screening

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

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

    Data type

    boolean

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

    day/month/year

    Data type

    date

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

    blood sample has not been taken

    Data type

    text

    Alias
    UMLS CUI [1]
    C0005834
    Biochemistry
    Description

    Biochemistry

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

    ND = not done

    Data type

    integer

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

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

    Data type

    integer

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

    ND = not done

    Data type

    integer

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

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

    Data type

    integer

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

    Serology

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

    ND = not done

    Data type

    integer

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

    ND = not done

    Data type

    integer

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

    ND = not done

    Data type

    integer

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

    ND = not done

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0019168
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Comments, if any
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Date :
    Description

    day/month/year

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Investigator Signature :
    Description

    Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Back to the top of the page

    Similar models

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

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial