0 Evaluaciones
ID

36259

Descripción

Study ID: 103792 Clinical Study ID: 103792 Study Title: A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289172 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: BIO ROTA; Rotarix Study Indication: Infections, Rotavirus

Palabras clave

Versiones (1)
  1. 25/4/19 25/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

25 de abril de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    GSK Biologicals' oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants; NCT00289172

    Inglés

    Medication

    1 formularios  
    1. StudyEvent: ODM
      1. Medication
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Descripción

    Clinical Trial Subject Unique Identifier

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Medication
    Descripción

    Medication

    Alias
    UMLS CUI-1
    C0013227
    Have any medications/treatments been administered during study period?
    Descripción

    If Yes, please complete the following table.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C2603343
    Trade / Generic Name
    Descripción

    Pharmaceutical Preparations, Medication name

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2360065
    Medical Indication
    Descripción

    Pharmaceutical Preparations, Indication

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C3146298
    Total daily dose
    Descripción

    Pharmaceutical Preparations, Daily Dose, Total

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2348070
    UMLS CUI [1,3]
    C0439810
    Route
    Descripción

    Pharmaceutical Preparations, Drug Administration Routes

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0013153
    Start Date
    Descripción

    Pharmaceutical Preparations, Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    End Date
    Descripción

    Pharmaceutical Preparations, End Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Tick box if continuing at end of study
    Descripción

    Pharmaceutical Preparations, Continuous

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
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    Similar models

    Medication

    1 formularios
    1. StudyEvent: ODM
      1. Medication
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Pharmaceutical Preparations, During, Study
    Item
    Have any medications/treatments been administered during study period?
    boolean
    C0013227 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C2603343 (UMLS CUI [1,3])
    Pharmaceutical Preparations, Medication name
    Item
    Trade / Generic Name
    text
    C0013227 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Indication
    Item
    Medical Indication
    text
    C0013227 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Daily Dose, Total
    Item
    Total daily dose
    text
    C0013227 (UMLS CUI [1,1])
    C2348070 (UMLS CUI [1,2])
    C0439810 (UMLS CUI [1,3])
    Pharmaceutical Preparations, Drug Administration Routes
    Item
    Route
    text
    C0013227 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Start Date
    Item
    Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Pharmaceutical Preparations, End Date
    Item
    End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Continuous
    Item
    Tick box if continuing at end of study
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Volver a la parte superior de la página 

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