0 Evaluaciones
ID

35889

Descripción

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

Palabras clave

Versiones (1)
  1. 2/4/19 2/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

2 de abril de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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

    Inglés

    Rash / Exanthema

    1 formularios  
    1. StudyEvent: ODM
      1. Rash / Exanthema
    Administrative Data
    Descripción

    Administrative Data

    Subject Number
    Descripción

    Clinical Trial Subject Unique Identifier

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Rash / Exanthema
    Descripción

    Rash / Exanthema

    Alias
    UMLS CUI-1
    C0015230
    Rash No.
    Descripción

    Exanthema, Numbers

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0237753
    Description
    Descripción

    Exanthema, Description

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0678257
    Description
    Descripción

    Exanthema, Description

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0678257
    If Localized, Localisation
    Descripción

    Exanthema, Localisation

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0475264
    If Administrazion site, Vaccine
    Descripción

    Exanthema, Administration of Vaccine

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C2368628
    Category
    Descripción

    Exanthema, Category

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0683312
    Date started
    Descripción

    Exanthema, Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0808070
    Date stopped
    Descripción

    Exanthema, End Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0806020
    Intensity
    Descripción

    Exanthema, Intensity

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0518690
    Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Descripción

    Exanthema, Relationship, Experimental drug

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0304229
    Outcome
    Descripción

    Exanthema, Outcome

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0015230
    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
    Descripción

    Exanthema, Visit, advice, medical

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C1386497
    Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
    Descripción

    Exanthema, Visit, advice, medical, Type

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [1,4]
    C0332307
    Volver a la parte superior de la página

    Similar models

    Rash / Exanthema

    1 formularios
    1. StudyEvent: ODM
      1. Rash / Exanthema
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Volver a la parte superior de la página 

    Ayuda

    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