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ID

32631

Descrizione

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

versioni (2)
  1. 31/10/18 31/10/18 -
  2. 09/11/18 09/11/18 - Sarah Riepenhausen
Titolare del copyright

GlaxoSmithKline

Caricato su

9 novembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

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

    Inglese

    Demography

    1 moduli  
    1. StudyEvent: ODM
      1. Demography
    Administrative Data
    Descrizione

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Visit Date
    Descrizione

    Visit Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Subject Identifier
    Descrizione

    Subject Identifier

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Demography
    Descrizione

    Demography

    Alias
    UMLS CUI-1
    C0011298 (Demography)
    LOINC
    LP204151-7
    Date of birth
    Descrizione

    Date of birth

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    Sex
    Descrizione

    Sex

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    Ethnicity, tick one:
    Descrizione

    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

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0015031 (Ethnic group)
    SNOMED
    398089004
    LOINC
    LP36231-6
    Race: African American/African Heritage
    Descrizione

    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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0085756 (African American)
    SNOMED
    15086000
    LOINC
    LA10610-6
    UMLS CUI [2]
    C0027567 (African race)
    SNOMED
    413464008
    Race: American Indian or Alaskan Native
    Descrizione

    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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1515945 (American Indian or Alaska Native)
    SNOMED
    413490006
    LOINC
    LA10608-0
    Race: Asian - Central/South Asian Heritage
    Descrizione

    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)

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0238696 (Central Asian)
    UMLS CUI [2]
    C1519427 (South Asian)
    Race: Asian - East Asian Heritage
    Descrizione

    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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C4540996 (East Asian ethnicity)
    Race: Asian - Japanese Heritage
    Descrizione

    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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1556094 (Japanese race)
    SNOMED
    414551003
    LOINC
    LA4595-0
    Race: Asian - South East Asian Heritage
    Descrizione

    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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0238697 (South East Asian)
    SNOMED
    186044009
    Race: Native Hawaiian or Other Pacific Islander
    Descrizione

    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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1513907 (Native Hawaiian or Other Pacific Islander)
    LOINC
    LA10611-4
    Race: White - Arabic/North African Heritage
    Descrizione

    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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0238604 (North African)
    UMLS CUI [2]
    C0026068 (Middle East)
    SNOMED
    223605000
    Race: White - White/Caucasian/European Heritage
    Descrizione

    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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0043157 (Caucasians)
    SNOMED
    185984009
    LOINC
    LA23729-9
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    Similar models

    Demography

    1 moduli
    1. StudyEvent: ODM
      1. Demography
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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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