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ID

34024

Beschrijving

Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders The purpose of this form is to document the subjects demographic data.

Trefwoorden

  1. 11-01-19 11-01-19 -
  2. 11-01-19 11-01-19 -
  3. 17-01-19 17-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

    Demographics

    1. StudyEvent: ODM
      1. Demographics
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschrijving

    Subject Identifier

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Beschrijving

    Visit Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    Demography
    Beschrijving

    Demography

    Alias
    UMLS CUI-1
    C0011298
    Date of Birth
    Beschrijving

    Date of Birth

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Beschrijving

    Sex

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0079399
    Ethnicity
    Beschrijving

    Tick one

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0015031
    Race
    Beschrijving

    Race

    Alias
    UMLS CUI-1
    C0034510
    African American/African Heritage
    Beschrijving

    African American/African Heritage

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0085756
    UMLS CUI [1,2]
    C0027567
    American Indian or Alaskan Native
    Beschrijving

    American Indian or Alaskan Native

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1515945
    Asian - Central/South Asian Heritage
    Beschrijving

    Asian - Central/South Asian Heritage

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0238696
    UMLS CUI [1,2]
    C1519427
    Asian - East Asian Heritage
    Beschrijving

    Asian - East Asian Heritage

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C4540996
    Asian - Japanese Heritage
    Beschrijving

    Asian - Japanese Heritage

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1556094
    Asian - South East Asian Heritage
    Beschrijving

    Asian - South East Asian Heritage

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0238697
    Native Hawaiian or Other Pacific Islander
    Beschrijving

    Native Hawaiian or Other Pacific Islander

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1513907
    White - Arabic/North African Heritage
    Beschrijving

    White - Arabic/North African Heritage

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0238604
    UMLS CUI [1,2]
    C1552588
    White - White/Caucasian/European Heritage
    Beschrijving

    White - White/Caucasian/European Heritage

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0043157

    Similar models

    Demographics

    1. StudyEvent: ODM
      1. Demographics
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Demography
    C0011298 (UMLS CUI-1)
    Date of Birth
    Item
    Date of Birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Code List
    Sex
    CL Item
    Male (m)
    CL Item
    female (f)
    Item
    Ethnicity
    integer
    C0015031 (UMLS CUI [1])
    Code List
    Ethnicity
    CL Item
    Hispanic or Latino (1)
    CL Item
    Not Hispanic or Latino (2)
    Item Group
    Race
    C0034510 (UMLS CUI-1)
    African American/African Heritage
    Item
    African American/African Heritage
    boolean
    C0085756 (UMLS CUI [1,1])
    C0027567 (UMLS CUI [1,2])
    American Indian or Alaskan Native
    Item
    American Indian or Alaskan Native
    boolean
    C1515945 (UMLS CUI [1])
    Asian - Central/South Asian Heritage
    Item
    Asian - Central/South Asian Heritage
    boolean
    C0238696 (UMLS CUI [1,1])
    C1519427 (UMLS CUI [1,2])
    Asian - East Asian Heritage
    Item
    Asian - East Asian Heritage
    boolean
    C4540996 (UMLS CUI [1])
    Asian - Japanese Heritage
    Item
    Asian - Japanese Heritage
    boolean
    C1556094 (UMLS CUI [1])
    Asian - South East Asian Heritage
    Item
    Asian - South East Asian Heritage
    boolean
    C0238697 (UMLS CUI [1])
    Native Hawaiian or Other Pacific Islander
    Item
    Native Hawaiian or Other Pacific Islander
    boolean
    C1513907 (UMLS CUI [1])
    White - Arabic/North African Heritage
    Item
    White - Arabic/North African Heritage
    boolean
    C0238604 (UMLS CUI [1,1])
    C1552588 (UMLS CUI [1,2])
    White - White/Caucasian/European Heritage
    Item
    White - White/Caucasian/European Heritage
    boolean
    C0043157 (UMLS CUI [1])

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