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ID

35891

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

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

GlaxoSmithKline

Uploaded on

April 2, 2019

DOI

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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

    Febrile Convulsions - Suspected Signs of Meningitis Events

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Subject Number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Febrile Convulsions - Suspected Signs of Meningitis Events
    Description

    Febrile Convulsions - Suspected Signs of Meningitis Events

    Alias
    UMLS CUI-1
    C0009952
    UMLS CUI-2
    C0025287
    FC No.
    Description

    Febrile Convulsions, Numbers

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0237753
    Description
    Description

    Febrile Convulsions, Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0678257
    Date started
    Description

    Febrile Convulsions, Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0808070
    Date stopped
    Description

    Febrile Convulsions, End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0806020
    Intensity
    Description

    Febrile Convulsions, Intensity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0518690
    Was a neurological examination performed?
    Description

    Febrile Convulsions, Neurologic Examination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0027853
    if yes, was a lumbar puncture performed?
    Description

    if yes, please send a copy of Medical Report

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0037943
    Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Description

    Febrile Convulsions, Relationship, Experimental drug

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0304229
    Outcome
    Description

    Febrile Convulsions, Outcome

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C1547647
    Medically attended visit (Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
    Description

    Febrile Convulsions, Visit, advice, medical

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C1386497
    Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
    Description

    Febrile Convulsions, Visit, advice, medical, Type

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [1,4]
    C0332307
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    Similar models

    Febrile Convulsions - Suspected Signs of Meningitis Events

    1 forms
    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
    Febrile Convulsions - Suspected Signs of Meningitis Events
    C0009952 (UMLS CUI-1)
    C0025287 (UMLS CUI-2)
    Item
    FC No.
    text
    C0009952 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Exanthema, Numbers
    Code List
    FC No.
    CL Item
    FC.1 (1)
    CL Item
    FC.2 (2)
    Febrile Convulsions, Description
    Item
    Description
    text
    C0009952 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Febrile Convulsions, Start Date
    Item
    Date started
    date
    C0009952 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Febrile Convulsions, End Date
    Item
    Date stopped
    date
    C0009952 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Intensity
    text
    C0009952 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Exanthema, Intensity
    Code List
    Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    Febrile Convulsions, Neurologic Examination
    Item
    Was a neurological examination performed?
    boolean
    C0009952 (UMLS CUI [1,1])
    C0027853 (UMLS CUI [1,2])
    Febrile Convulsions, Spinal Puncture
    Item
    if yes, was a lumbar puncture performed?
    boolean
    C0009952 (UMLS CUI [1,1])
    C0037943 (UMLS CUI [1,2])
    Febrile Convulsions, 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
    C0009952 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Item
    Outcome
    text
    C0009952 (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)
    Febrile Convulsions, 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
    C0009952 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    Febrile Convulsions, Visit, advice, medical, Type
    Item
    Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
    boolean
    C0009952 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0332307 (UMLS CUI [1,4])
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