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ID

22995

Description

Study ID: 100484 Clinical Study ID: 100484 (DTPa) Study Title: An open prospective study of immunogenicity and reactogenicity of DTPa vaccine (Infanrix) given as a booster to healthy school children 10 to 12 years of age Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed Trade Name: BIO DTPA (INFANRIX); Infanrix Study Indication: Acellular Pertussis; Diphtheria; Tetanus; acellular pertussis Documentation: Medication

Keywords

  1. 19.06.17 19.06.17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

19. Juni 2017

DOI

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Creative Commons BY-NC 3.0

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    Medication: GSK DTPa vaccine (Infanrix) 100484

    Study ID: 100484 Medication

    Medication
    Description

    Medication

    Alias
    UMLS CUI-1
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI-2
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    Have any medications/treatments been administered during study period?
    Description

    Medication

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [2]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    Trade or generic name
    Description

    Medication name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Medical Indication
    Description

    Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3146298 (Indication)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Total daily dose
    Description

    Total daily dose

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348070 (Daily Dose)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Route
    Description

    Administration Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Start Date
    Description

    Medication Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070 (Start Date)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    End Date
    Description

    Medication End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    or tick box if continuing at end of study
    Description

    Medication Ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)

    Similar models

    Study ID: 100484 Medication

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    C0087111 (UMLS CUI-2)
    Item
    Have any medications/treatments been administered during study period?
    integer
    C0013227 (UMLS CUI [1])
    C0087111 (UMLS CUI [2])
    Code List
    Have any medications/treatments been administered during study period?
    CL Item
    No (1)
    CL Item
    Yes, please complete the following table. (2)
    Medication name
    Item
    Trade or generic name
    text
    C2360065 (UMLS CUI [1])
    Indication
    Item
    Medical Indication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Total daily dose
    Item
    Total daily dose
    text
    C2348070 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Code List
    Route
    CL Item
    External (EXT)
    CL Item
    Intradermal (ID)
    CL Item
    Inhalation (IH)
    CL Item
    Intramuscular (IM)
    CL Item
    Intraarticular (IR)
    CL Item
    Intrathecal (IT)
    CL Item
    Intravenous (IV)
    CL Item
    Intranasal (NA)
    CL Item
    Other (OTH)
    CL Item
    Parenteral (PE)
    CL Item
    Oral (PO)
    CL Item
    Rectal (PR)
    CL Item
    Subcutaneous (SC)
    CL Item
    Sublingual (SL)
    CL Item
    Transdermal (TD)
    CL Item
    Topical (TO)
    CL Item
    Unknown (UNK)
    CL Item
    Vaginal (VA)
    Medication Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Medication End Date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Medication Ongoing
    Item
    or tick box if continuing at end of study
    boolean
    C2826666 (UMLS CUI [1])

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