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23907

Description

Study part: Extensive Swelling Report. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

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Versions (1)
  1. 7/17/17 7/17/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 17, 2017

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Creative Commons BY-NC 3.0
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    Extensive Swelling Report Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

    English

    Extensive Swelling Report

    1 forms  
    EXTENSIVE SWELLING REPORT
    Description

    EXTENSIVE SWELLING REPORT

    Alias
    UMLS CUI-1
    C0684224
    UMLS CUI-2
    C0038999
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Vaccine administered for which the extensive swelling is reported:
    Description

    vaccines

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042210
    1. Date of physical examination
    Description

    Date of physical examination

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0031809
    Was the examination performed by a member of study personnel during the extensive swelling period :
    Description

    Research Personnel; physical examination swelling

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0035173
    UMLS CUI [2,1]
    C0031809
    UMLS CUI [2,2]
    C0038999
    2. Date when the swelling was first considered to be extensive:
    Description

    Date swelling

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0038999
    If occurring within 24 hours after vaccination, please specify how long after vaccination:
    Description

    Swelling; Vaccination

    Data type

    text

    Alias
    UMLS CUI [1]
    C0038999
    UMLS CUI [2]
    C0042196
    3. Size of swelling:
    Description

    Measurement of the greatest diameter

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C0456389
    mm
    4. Type of swelling:
    Description

    Type

    Data type

    text

    Alias
    UMLS CUI [1]
    C0332307
    5. Circumference of swollen limb (at the site of maximum swelling):
    Description

    Circumference Swelling limb

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0424682
    UMLS CUI [1,2]
    C0038999
    UMLS CUI [1,3]
    C0015385
    mm
    5. Circumference of the opposite limb (at the same level):
    Description

    Circumference limb

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0424682
    UMLS CUI [1,2]
    C0015385
    UMLS CUI [1,3]
    C1521805
    mm
    6. Associated signs: Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0039476
    °C
    Route:
    Description

    Body temperature measurement site

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0489453
    6. Associated signs: Redness
    Description

    Redness

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0332575
    Largest diameter :
    Description

    diameter

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C1301886
    mm
    6. Associated signs: Induration
    Description

    Induration

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0332534
    Largest diameter :
    Description

    diameter

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C1301886
    mm
    6. Associated signs: Pain (at administration site)
    Description

    Pain

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030193
    Intensity
    Description

    Intensity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0518690
    6. Associated signs: Functional impairment
    Description

    Functional impairment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4062321
    Intensity
    Description

    Intensity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0518690
    7. Please give a clinical description of the observed extensive swelling, including a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s) procedures and therapeutic interventions.
    Description

    Swelling Description; diagnostic procedure; therapeutic interventions.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0678257
    UMLS CUI [2]
    C0430022
    UMLS CUI [3]
    C0808232
    8. Last date when the swelling was still considered to be extensive:
    Description

    Last date swelling

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3260033
    UMLS CUI [1,2]
    C0038999
    If lasting for less than 24 hours, please specify duration (hours):
    Description

    Duration Swelling

    Data type

    integer

    Measurement units
    • hours
    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C0038999
    hours
    9. Outcome of the swelling:
    Description

    Outcome swelling

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1705586
    UMLS CUI [1,2]
    C0038999
    10. Is there an alternative explanation for the swelling? (e.g. : allergy, infection, trauma, underlying conditions)
    Description

    causality allergy infection trauma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1314792
    UMLS CUI [1,2]
    C0020517
    UMLS CUI [1,3]
    C0009450
    UMLS CUI [1,4]
    C3714660
    If yes, please specify:
    Description

    Specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C1521902
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    Similar models

    Extensive Swelling Report

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    EXTENSIVE SWELLING REPORT
    C0684224 (UMLS CUI-1)
    C0038999 (UMLS CUI-2)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item
    Vaccine administered for which the extensive swelling is reported:
    text
    C0042210 (UMLS CUI [1])
    vaccines
    Code List
    Vaccine administered for which the extensive swelling is reported:
    CL Item
    Hib-MenCY OR Hib-MenC Vaccine [ 9 0 1 ] (1)
    CL Item
    MenC Vaccine [ 9 0 2 ] (2)
    CL Item
    DTPa-HBV-IPV Vaccine [ 1 4 ] (3)
    CL Item
    DTPa-HBV-IPV/Hib Vaccine [ 3 8 ] (4)
    Date of physical examination
    Item
    1. Date of physical examination
    date
    C0011008 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
    Research Personnel; physical examination swelling
    Item
    Was the examination performed by a member of study personnel during the extensive swelling period :
    boolean
    C0035173 (UMLS CUI [1])
    C0031809 (UMLS CUI [2,1])
    C0038999 (UMLS CUI [2,2])
    Date swelling
    Item
    2. Date when the swelling was first considered to be extensive:
    date
    C0011008 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    Swelling; Vaccination
    Item
    If occurring within 24 hours after vaccination, please specify how long after vaccination:
    text
    C0038999 (UMLS CUI [1])
    C0042196 (UMLS CUI [2])
    Size
    Item
    3. Size of swelling:
    float
    C0456389 (UMLS CUI [1])
    Item
    4. Type of swelling:
    text
    C0332307 (UMLS CUI [1])
    Type
    Code List
    4. Type of swelling:
    CL Item
    Local swelling around injection site, not involving adjacent joint (Local swelling around injection site, not involving adjacent joint)
    CL Item
    Diffuse swelling, not involving adjacent joint (Diffuse swelling, not involving adjacent joint)
    CL Item
    Swelling, involving adjacent joint (Swelling, involving adjacent joint)
    Circumference Swelling limb
    Item
    5. Circumference of swollen limb (at the site of maximum swelling):
    float
    C0424682 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    C0015385 (UMLS CUI [1,3])
    Circumference limb
    Item
    5. Circumference of the opposite limb (at the same level):
    float
    C0424682 (UMLS CUI [1,1])
    C0015385 (UMLS CUI [1,2])
    C1521805 (UMLS CUI [1,3])
    Temperature
    Item
    6. Associated signs: Temperature
    float
    C0039476 (UMLS CUI [1])
    Item
    Route:
    integer
    C0489453 (UMLS CUI [1])
    body temperature
    Code List
    Route:
    CL Item
    Axillary [ A ] (1)
    C0004454 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Rectal [ R ] (2)
    C0205052 (UMLS CUI-1)
    (Comment:en)
    Redness
    Item
    6. Associated signs: Redness
    boolean
    C0332575 (UMLS CUI [1])
    diameter
    Item
    Largest diameter :
    integer
    C1301886 (UMLS CUI [1])
    Induration
    Item
    6. Associated signs: Induration
    boolean
    C0332534 (UMLS CUI [1])
    diameter
    Item
    Largest diameter :
    integer
    C1301886 (UMLS CUI [1])
    Pain
    Item
    6. Associated signs: Pain (at administration site)
    boolean
    C0030193 (UMLS CUI [1])
    Item
    Intensity
    integer
    C0518690 (UMLS CUI [1])
    Intensity
    Code List
    Intensity
    CL Item
    grade 1: Minor reaction to touch (1)
    CL Item
    grade 2: Cries / protests on touch (2)
    CL Item
    grade 3: Cries when limb is moved /spontaneously painful (3)
    Functional impairment
    Item
    6. Associated signs: Functional impairment
    boolean
    C4062321 (UMLS CUI [1])
    Item
    Intensity
    integer
    C0518690 (UMLS CUI [1])
    Intensity
    Code List
    Intensity
    CL Item
    grade 1: easily tolerated, causing minimal discomfort and not interfering with everyday activities (1)
    CL Item
    grade 2: sufficiently discomforting to interfere with normal everyday activities (2)
    CL Item
    grade 3: prevents normal everyday activities (3)
    Swelling Description; diagnostic procedure; therapeutic interventions.
    Item
    7. Please give a clinical description of the observed extensive swelling, including a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s) procedures and therapeutic interventions.
    text
    C0038999 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    C0430022 (UMLS CUI [2])
    C0808232 (UMLS CUI [3])
    Last date swelling
    Item
    8. Last date when the swelling was still considered to be extensive:
    date
    C3260033 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    Duration Swelling
    Item
    If lasting for less than 24 hours, please specify duration (hours):
    integer
    C0449238 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    Item
    9. Outcome of the swelling:
    integer
    C1705586 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    Outcome swelling
    Code List
    9. Outcome of the swelling:
    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)
    causality allergy infection trauma
    Item
    10. Is there an alternative explanation for the swelling? (e.g. : allergy, infection, trauma, underlying conditions)
    boolean
    C1314792 (UMLS CUI [1,1])
    C0020517 (UMLS CUI [1,2])
    C0009450 (UMLS CUI [1,3])
    C3714660 (UMLS CUI [1,4])
    Specify
    Item
    If yes, please specify:
    text
    C1521902 (UMLS CUI [1])
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