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ID

35890

Beschrijving

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

Trefwoorden

Versies (1)
  1. 02-04-19 02-04-19 -
Houder van rechten

GlaxoSmithKline

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2 april 2019

DOI

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Licentie

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

    Engels

    Parotid / Salivary Gland Swelling Events

    1 Formulieren  
    Administrative Data
    Beschrijving

    Administrative Data

    Subject Number
    Beschrijving

    Clinical Trial Subject Unique Identifier

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Parotid / Salivary Gland Swelling Events
    Beschrijving

    Parotid / Salivary Gland Swelling Events

    Alias
    UMLS CUI-1
    C0240925
    UMLS CUI-2
    C0240668
    PS No.
    Beschrijving

    Swelling of salivary gland, Numbers; parotid gland swelling, Numbers

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0240925
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2,1]
    C0240668
    UMLS CUI [2,2]
    C0237753
    Description
    Beschrijving

    Swelling of salivary gland, Description; parotid gland swelling, Description

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0240925
    UMLS CUI [1,2]
    C0678257
    UMLS CUI [2,1]
    C0240668
    UMLS CUI [2,2]
    C0678257
    Date started
    Beschrijving

    Swelling of salivary gland, Start Date; parotid gland swelling, Start Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0240925
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [2,1]
    C0240668
    UMLS CUI [2,2]
    C0808070
    Date stopped
    Beschrijving

    Swelling of salivary gland, End Date; parotid gland swelling, End Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0240925
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [2,1]
    C0240668
    UMLS CUI [2,2]
    C0806020
    Intensity
    Beschrijving

    Swelling of salivary gland, Intensity; parotid gland swelling, Intensity

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0240925
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [2,1]
    C0240668
    UMLS CUI [2,2]
    C0518690
    Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Beschrijving

    Swelling of salivary gland, Relationship, Experimental drug; parotid gland swelling, Relationship, Experimental drug

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0240925
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0304229
    UMLS CUI [2,1]
    C0240668
    UMLS CUI [2,2]
    C0439849
    UMLS CUI [2,3]
    C0304229
    Outcome
    Beschrijving

    Swelling of salivary gland, Outcome; parotid gland swelling, Outcome

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0240925
    UMLS CUI [1,2]
    C1547647
    UMLS CUI [2,1]
    C0240668
    UMLS CUI [2,2]
    C1547647
    Medically attended visit (Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
    Beschrijving

    Swelling of salivary gland, Visit, advice, medical; parotid gland swelling, Visit, advice, medical

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0240925
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2,1]
    C0240668
    UMLS CUI [2,2]
    C0545082
    UMLS CUI [2,3]
    C1386497
    Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
    Beschrijving

    Swelling of salivary gland, Visit, advice, medical, Type; parotid gland swelling, Visit, advice, medical Type

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0240925
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [1,4]
    C0332307
    UMLS CUI [2,1]
    C0240668
    UMLS CUI [2,2]
    C0545082
    UMLS CUI [2,3]
    C1386497
    UMLS CUI [2,4]
    C0332307
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    Similar models

    Parotid / Salivary Gland Swelling Events

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Parotid / Salivary Gland Swelling Events
    C0240925 (UMLS CUI-1)
    C0240668 (UMLS CUI-2)
    Item
    PS No.
    text
    C0240925 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C0240668 (UMLS CUI [2,1])
    C0237753 (UMLS CUI [2,2])
    Exanthema, Numbers
    Code List
    PS No.
    CL Item
    PS.1 (1)
    CL Item
    PS.2 (2)
    Swelling of salivary gland, Description; parotid gland swelling, Description
    Item
    Description
    text
    C0240925 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    C0240668 (UMLS CUI [2,1])
    C0678257 (UMLS CUI [2,2])
    Swelling of salivary gland, Start Date; parotid gland swelling, Start Date
    Item
    Date started
    date
    C0240925 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C0240668 (UMLS CUI [2,1])
    C0808070 (UMLS CUI [2,2])
    Swelling of salivary gland, End Date; parotid gland swelling, End Date
    Item
    Date stopped
    date
    C0240925 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C0240668 (UMLS CUI [2,1])
    C0806020 (UMLS CUI [2,2])
    Item
    Intensity
    text
    C0240925 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0240668 (UMLS CUI [2,1])
    C0518690 (UMLS CUI [2,2])
    Exanthema, Intensity
    Code List
    Intensity
    CL Item
    Swelling without difficulties to move the jaw. (1)
    CL Item
    Swelling with difficulties to move the jaw. (2)
    CL Item
    Swelling and additional general symptoms. (3)
    Swelling of salivary gland, Relationship, Experimental drug; parotid gland swelling, 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
    C0240925 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    C0240668 (UMLS CUI [2,1])
    C0439849 (UMLS CUI [2,2])
    C0304229 (UMLS CUI [2,3])
    Item
    Outcome
    text
    C0240925 (UMLS CUI [1,1])
    C1547647 (UMLS CUI [1,2])
    C0240668 (UMLS CUI [2,1])
    C1547647 (UMLS CUI [2,2])
    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)
    Swelling of salivary gland, Visit, advice, medical; parotid gland swelling, 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
    C0240925 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0240668 (UMLS CUI [2,1])
    C0545082 (UMLS CUI [2,2])
    C1386497 (UMLS CUI [2,3])
    Swelling of salivary gland, Visit, advice, medical, Type; parotid gland swelling, Visit, advice, medical Type
    Item
    Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
    boolean
    C0240925 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C0332307 (UMLS CUI [1,4])
    C0240668 (UMLS CUI [2,1])
    C0545082 (UMLS CUI [2,2])
    C1386497 (UMLS CUI [2,3])
    C0332307 (UMLS CUI [2,4])
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