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ID

26277

Description

Visit 6 Booster Dose Diary Card - Local Symptoms Biologicals HepA/HepB vaccine 208127/125 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

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Versions (1)
  1. 10/15/17 10/15/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 15, 2017

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License

Creative Commons BY-NC 3.0
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    Visit 6 Booster Dose Diary Card - Local Symptoms Biologicals HepA/HepB vaccine 208127/125

    English

    Visit 6 Booster Dose Diary Card - Local Symptoms 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
    Subject number
    Description

    Subject number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Redness
    Description

    Redness

    Alias
    UMLS CUI-1
    C0332575
    Size Day 0
    Description

    Size Day 0

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C2826301
    mm
    Size Day 1
    Description

    Size Day 1

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C1442449
    mm
    Size Day 2
    Description

    Size Day 2

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C3842676
    mm
    Size Day 3
    Description

    Size Day 3

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C3842675
    mm
    Swellling
    Description

    Swellling

    Alias
    UMLS CUI-1
    C0038999
    Size Day 0
    Description

    Size Day 0

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C2826301
    mm
    Size Day 1
    Description

    Size Day 1

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C1442449
    mm
    Size Day 2
    Description

    Size Day 2

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C3842676
    mm
    Size Day 3
    Description

    Size Day 3

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C3842675
    mm
    Soreness
    Description

    Soreness

    Alias
    UMLS CUI-1
    C0030193
    Intensity Day 0
    Description

    Intensity Day 0

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C2826301
    Intensity Day 1
    Description

    Intensity Day 1

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C1442449
    Intensity Day 2
    Description

    Intensity Day 2

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C3842676
    Intensity Day 3
    Description

    Intensity Day 3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C3842675
    Other Local Symptoms
    Description

    Other Local Symptoms

    Alias
    UMLS CUI-1
    C0205394
    UMLS CUI-2
    C1457887
    UMLS CUI-3
    C0205276
    OTHER : Please give details below (description - start date - end date - intensity)
    Description

    Description, start date, end date, intensity

    Data type

    text

    Alias
    UMLS CUI [1]
    C0424450
    UMLS CUI [2]
    C0808070
    UMLS CUI [3]
    C0806020
    UMLS CUI [4]
    C0518690
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    Similar models

    Visit 6 Booster Dose Diary Card - Local Symptoms 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])
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Redness
    C0332575 (UMLS CUI-1)
    Size Day 0
    Item
    Size Day 0
    integer
    C0456389 (UMLS CUI [1,1])
    C2826301 (UMLS CUI [1,2])
    Size Day 1
    Item
    Size Day 1
    integer
    C0456389 (UMLS CUI [1,1])
    C1442449 (UMLS CUI [1,2])
    Size Day 2
    Item
    Size Day 2
    integer
    C0456389 (UMLS CUI [1,1])
    C3842676 (UMLS CUI [1,2])
    Size Day 3
    Item
    Size Day 3
    integer
    C0456389 (UMLS CUI [1,1])
    C3842675 (UMLS CUI [1,2])
    Item Group
    Swellling
    C0038999 (UMLS CUI-1)
    Size Day 0
    Item
    Size Day 0
    integer
    C0456389 (UMLS CUI [1,1])
    C2826301 (UMLS CUI [1,2])
    Size Day 1
    Item
    Size Day 1
    integer
    C0456389 (UMLS CUI [1,1])
    C1442449 (UMLS CUI [1,2])
    Size Day 2
    Item
    Size Day 2
    integer
    C0456389 (UMLS CUI [1,1])
    C3842676 (UMLS CUI [1,2])
    Size Day 3
    Item
    Size Day 3
    integer
    C0456389 (UMLS CUI [1,1])
    C3842675 (UMLS CUI [1,2])
    Item Group
    Soreness
    C0030193 (UMLS CUI-1)
    Item
    Intensity Day 0
    integer
    C0518690 (UMLS CUI [1,1])
    C2826301 (UMLS CUI [1,2])
    Intensity Day 0
    Code List
    Intensity Day 0
    CL Item
    Nihil  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    Intensity Day 1
    integer
    C0518690 (UMLS CUI [1,1])
    C1442449 (UMLS CUI [1,2])
    Intensity Day 0
    Code List
    Intensity Day 1
    CL Item
    Nihil  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    Intensity Day 2
    integer
    C0518690 (UMLS CUI [1,1])
    C3842676 (UMLS CUI [1,2])
    Intensity Day 0
    Code List
    Intensity Day 2
    CL Item
    Nihil  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item
    Intensity Day 3
    integer
    C0518690 (UMLS CUI [1,1])
    C3842675 (UMLS CUI [1,2])
    Intensity Day 3
    Code List
    Intensity Day 3
    CL Item
    Nihil  (0)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Item Group
    Other Local Symptoms
    C0205394 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    C0205276 (UMLS CUI-3)
    Description, start date, end date, intensity
    Item
    OTHER : Please give details below (description - start date - end date - intensity)
    text
    C0424450 (UMLS CUI [1])
    C0808070 (UMLS CUI [2])
    C0806020 (UMLS CUI [3])
    C0518690 (UMLS CUI [4])
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