0 Ratings
ID

38538

Description

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

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Versions (2)
  1. 9/22/19 9/22/19 -
  2. 10/24/19 10/24/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 24, 2019

DOI

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License

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

    English

    Subject Logs

    1 forms  
    1. StudyEvent: ODM
      1. Subject Logs
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Site
    Description

    Study Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164
    Patient
    Description

    Patient name

    Data type

    text

    Alias
    UMLS CUI [1]
    C1299487
    Patient No
    Description

    Patients, Identification number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1300638
    Date of Visit/Assessment
    Description

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303
    UMLS CUI-2
    C2985720
    Date of visit/assessment
    Description

    Date of visit; Assessment Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Log Status
    Description

    Log Status

    Alias
    UMLS CUI-1
    C1708728
    UMLS CUI-2
    C0449438
    Did the subject experience a serious adverse event during the study?
    Description

    Serious Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    Description

    Concomitant Agent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Did the subject experience any non-serious adverse events during the study?
    Description

    Non-serious Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1518404
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    Similar models

    Subject Logs

    1 forms
    1. StudyEvent: ODM
      1. Subject Logs
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Back to the top of the page 

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