0 Ratings

ID

34012

Description

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.

Keywords

  1. 1/11/19 1/11/19 -
  2. 1/11/19 1/11/19 -
  3. 1/17/19 1/17/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 11, 2019

DOI

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License

Creative Commons BY-NC 3.0

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

    Demographics

    1. StudyEvent: ODM
      1. Demographics
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Demography
    Description

    Demography

    Alias
    UMLS CUI-1
    C0011298
    Date of Birth
    Description

    Date of Birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Description

    Sex

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Ethnicity
    Description

    Tick one

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015031
    Race
    Description

    Race

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

    African American/African Heritage

    Data type

    boolean

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

    American Indian or Alaskan Native

    Data type

    boolean

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

    Asian - Central/South Asian Heritage

    Data type

    boolean

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

    Asian - East Asian Heritage

    Data type

    boolean

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

    Asian - Japanese Heritage

    Data type

    boolean

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

    Asian - South East Asian Heritage

    Data type

    boolean

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

    Native Hawaiian or Other Pacific Islander

    Data type

    boolean

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

    White - Arabic/North African Heritage

    Data type

    boolean

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

    White - White/Caucasian/European Heritage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0043157

    Similar models

    Demographics

    1. StudyEvent: ODM
      1. Demographics
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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