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ID

35889

Description

Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Keywords

Versions (1)
  1. 4/2/19 4/2/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 2, 2019

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License

Creative Commons BY-NC 3.0
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    GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

    English

    Rash / Exanthema

    1 forms  
    1. StudyEvent: ODM
      1. Rash / Exanthema
    Administrative Data
    Description

    Administrative Data

    Subject Number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Rash / Exanthema
    Description

    Rash / Exanthema

    Alias
    UMLS CUI-1
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    Rash No.
    Description

    Exanthema, Numbers

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Description
    Description

    Exanthema, Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0678257 (Description)
    LOINC
    LP6800-9
    Description
    Description

    Exanthema, Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0678257 (Description)
    LOINC
    LP6800-9
    If Localized, Localisation
    Description

    Exanthema, Localisation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0475264 (localization)
    SNOMED
    257880008
    If Administrazion site, Vaccine
    Description

    Exanthema, Administration of Vaccine

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C2368628 (Administration of vaccine)
    Category
    Description

    Exanthema, Category

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0683312 (Categories)
    LOINC
    MTHU018876
    Date started
    Description

    Exanthema, Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Date stopped
    Description

    Exanthema, End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Intensity
    Description

    Exanthema, Intensity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0518690 (Symptom intensity)
    Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Description

    Exanthema, Relationship, Experimental drug

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0439849 (Relationships)
    SNOMED
    263498003
    LOINC
    LP146886-9
    UMLS CUI [1,3]
    C0304229 (Experimental drug)
    Outcome
    Description

    Exanthema, Outcome

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C1547647 (Patient Outcome)
    Medically attended visit (Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
    Description

    Exanthema, Visit, advice, medical

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0545082 (Visit)
    UMLS CUI [1,3]
    C1386497 (advice; medical)
    Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
    Description

    Exanthema, Visit, advice, medical, Type

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0545082 (Visit)
    UMLS CUI [1,3]
    C1386497 (advice; medical)
    UMLS CUI [1,4]
    C0332307 (Type - attribute)
    SNOMED
    261664005
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    Similar models

    Rash / Exanthema

    1 forms
    1. StudyEvent: ODM
      1. Rash / Exanthema
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Rash / Exanthema
    C0015230 (UMLS CUI-1)
    Item
    Rash No.
    text
    C0015230 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Exanthema, Numbers
    Code List
    Rash No.
    CL Item
    RA.1 (1)
    CL Item
    RA.2 (2)
    Exanthema, Description
    Item
    Description
    text
    C0015230 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Item
    Description
    text
    C0015230 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Exanthema, Description
    Code List
    Description
    CL Item
    Generalized (1)
    CL Item
    Localized (2)
    Item
    If Localized, Localisation
    text
    C0015230 (UMLS CUI [1,1])
    C0475264 (UMLS CUI [1,2])
    Exanthema, Description
    Code List
    If Localized, Localisation
    CL Item
    Administration site (1)
    CL Item
    Other location : specify : (2)
    Item
    If Administrazion site, Vaccine
    text
    C0015230 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    Exanthema, Description
    Code List
    If Administrazion site, Vaccine
    CL Item
    Hib-MenCY-TTvaccine (1)
    CL Item
    DM-M-R®II vaccine  (2)
    CL Item
    D Varivax® vaccine (3)
    CL Item
    D PedvaxHIB® vaccine (4)
    Item
    Category
    text
    C0015230 (UMLS CUI [1,1])
    C0683312 (UMLS CUI [1,2])
    Exanthema, Category
    Code List
    Category
    CL Item
    Varicella rash (1)
    CL Item
    Measles / rubella-rash (2)
    CL Item
    Other (3)
    Exanthema, Start Date
    Item
    Date started
    date
    C0015230 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Exanthema, End Date
    Item
    Date stopped
    date
    C0015230 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Intensity
    text
    C0015230 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Exanthema, Intensity
    Code List
    Intensity
    CL Item
    1–10lesions (1)
    CL Item
    11 – 30 lesions  (2)
    CL Item
    31 – 100 lesions  (3)
    CL Item
    101 – 200 lesions  (4)
    CL Item
    >200lesions (5)
    Exanthema, Relationship, Experimental drug
    Item
    Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C0015230 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Item
    Outcome
    text
    C0015230 (UMLS CUI [1,1])
    C1547647 (UMLS CUI [1,2])
    Exanthema, 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)
    Exanthema, Visit, advice, medical
    Item
    Medically attended visit (Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
    boolean
    C0015230 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    Exanthema, Visit, advice, medical, Type
    Item
    Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
    boolean
    C0015230 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0332307 (UMLS CUI [1,4])
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