0 Evaluaciones
ID

38538

Descripción

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Palabras clave

Versiones (2)
  1. 22/9/19 22/9/19 -
  2. 24/10/19 24/10/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

24 de octubre de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636

    Inglés

    Subject Logs

    1 formularios  
    1. StudyEvent: ODM
      1. Subject Logs
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Site
    Descripción

    Study Site

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2825164 (Study Site)
    Patient
    Descripción

    Patient name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1299487 (Patient name)
    SNOMED
    371484003
    Patient No
    Descripción

    Patients, Identification number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C1300638 (Identification number)
    SNOMED
    396278008
    Date of Visit/Assessment
    Descripción

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI-2
    C2985720 (Assessment Date)
    Date of visit/assessment
    Descripción

    Date of visit; Assessment Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [1,2]
    C2985720 (Assessment Date)
    Log Status
    Descripción

    Log Status

    Alias
    UMLS CUI-1
    C1708728 (Event Log)
    UMLS CUI-2
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    Did the subject experience a serious adverse event during the study?
    Descripción

    Serious Adverse Event

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1519255 (Serious Adverse Event)
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    Descripción

    Concomitant Agent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    Did the subject experience any non-serious adverse events during the study?
    Descripción

    Non-serious Adverse Event

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1518404 (Non-serious Adverse Event)
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    Subject Logs

    1 formularios
    1. StudyEvent: ODM
      1. Subject Logs
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Study Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Patient name
    Item
    Patient
    text
    C1299487 (UMLS CUI [1])
    Patients, Identification number
    Item
    Patient No
    integer
    C0030705 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Item Group
    Date of Visit/Assessment
    C1320303 (UMLS CUI-1)
    C2985720 (UMLS CUI-2)
    Date of visit; Assessment Date
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Log Status
    C1708728 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Serious Adverse Event
    Item
    Did the subject experience a serious adverse event during the study?
    boolean
    C1519255 (UMLS CUI [1])
    Concomitant Agent
    Item
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    boolean
    C2347852 (UMLS CUI [1])
    Non-serious Adverse Event
    Item
    Did the subject experience any non-serious adverse events during the study?
    boolean
    C1518404 (UMLS CUI [1])
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