0 Ratings
ID

35890

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

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

    English

    Parotid / Salivary Gland Swelling Events

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Subject Number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

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

    Parotid / Salivary Gland Swelling Events

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

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

    Data type

    text

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

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

    Data type

    text

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

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

    Data type

    date

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

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

    Data type

    date

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

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

    Data type

    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?
    Description

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

    Data type

    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
    Description

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

    Data type

    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
    Description

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

    Data type

    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
    Description

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

    Data type

    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
    Back to the top of the page

    Similar models

    Parotid / Salivary Gland Swelling 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
    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])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial