0 Ratings
ID

32631

Description

This ODM-file contains the form to document the demography of the subject. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 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

Keywords

Versions (2)
  1. 10/31/18 10/31/18 -
  2. 11/9/18 11/9/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

November 9, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

    English

    Demography

    1 forms  
    1. StudyEvent: ODM
      1. Demography
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    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, tick one:
    Description

    ETHNICITY • Hispanic or Latino A person of Cuban, Mexican, Puerto Rican, South American or other Spanish culture or origin, regardless of race Note: If the subject does not meet the definition above, ✔ Not Hispanic or Latino. • Not Hispanic or Latino Neither Hispanic or Latino

    Data type

    text

    Alias
    UMLS CUI [1]
    C0015031
    Race: African American/African Heritage
    Description

    The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 1] A person having origins in any of the black racial groups of Africa

    Data type

    boolean

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

    The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick✔ multiple boxes. [1 2] A person having origins in any of the original peoples of North and South America (including Central America) and who maintains tribal affiliation or community attachment

    Data type

    boolean

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

    The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 3] A person having origins in Central Asia and Indian Subcontinent (India, Pakistan, Bangladesh and Sri Lanka)

    Data type

    boolean

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

    The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 4] A person having origins in China, Korea

    Data type

    boolean

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

    The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 5] A person having origins in Japan

    Data type

    boolean

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

    The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 6] A person having origins in Malaysia, the Philippines, Indonesia, Thailand, Vietnam, Laos, Burma or Cambodia

    Data type

    boolean

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

    The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 7] A person having origins in any of the original peoples of Hawaii, Guam, Samoa or other Pacific Islands, Australia (Aborigines), Papua New Guinea, New Zealand, Marshalls and other island groups west and south of Japan

    Data type

    boolean

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

    The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 8] A person having origins in any of the original peoples of Middle East or North Africa

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0238604
    UMLS CUI [2]
    C0026068
    Race: White - White/Caucasian/European Heritage
    Description

    The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to tick multiple boxes. [1 9] A person having origins in any of the original peoples of Europe

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0043157
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    Similar models

    Demography

    1 forms
    1. StudyEvent: ODM
      1. Demography
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (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])
    Sex
    Code List
    Sex
    CL Item
    Male (M)
    CL Item
    Female (F)
    Item
    Ethnicity, tick one:
    text
    C0015031 (UMLS CUI [1])
    Ethnicity
    Code List
    Ethnicity, tick one:
    CL Item
    Hispanic or Latino (1)
    CL Item
    Not Hispanic or Latino (2)
    Race: African American/African Heritage
    Item
    Race: African American/African Heritage
    boolean
    C0085756 (UMLS CUI [1])
    C0027567 (UMLS CUI [2])
    Race: American Indian or Alaskan Native
    Item
    Race: American Indian or Alaskan Native
    boolean
    C1515945 (UMLS CUI [1])
    Race: Asian - Central/South Asian Heritage
    Item
    Race: Asian - Central/South Asian Heritage
    boolean
    C0238696 (UMLS CUI [1])
    C1519427 (UMLS CUI [2])
    Race: Asian - East Asian Heritage
    Item
    Race: Asian - East Asian Heritage
    boolean
    C4540996 (UMLS CUI [1])
    Race: Asian - Japanese Heritage
    Item
    Race: Asian - Japanese Heritage
    boolean
    C1556094 (UMLS CUI [1])
    Race: Asian - South East Asian Heritage
    Item
    Race: Asian - South East Asian Heritage
    boolean
    C0238697 (UMLS CUI [1])
    Race: Native Hawaiian or Other Pacific Islander
    Item
    Race: Native Hawaiian or Other Pacific Islander
    boolean
    C1513907 (UMLS CUI [1])
    Race: White - Arabic/North African Heritage
    Item
    Race: White - Arabic/North African Heritage
    boolean
    C0238604 (UMLS CUI [1])
    C0026068 (UMLS CUI [2])
    Race: White - White/Caucasian/European Heritage
    Item
    Race: White - White/Caucasian/European Heritage
    boolean
    C0043157 (UMLS CUI [1])
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