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

Versions (3)
  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

    English

    Demographics

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

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Demography
    Description

    Demography

    Alias
    UMLS CUI-1
    C0011298 (Demography)
    LOINC
    LP204151-7
    Date of Birth
    Description

    Date of Birth

    Data type

    date

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

    Sex

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    Ethnicity
    Description

    Tick one

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015031 (Ethnic group)
    SNOMED
    398089004
    LOINC
    LP36231-6
    Race
    Description

    Race

    Alias
    UMLS CUI-1
    C0034510 (Racial group)
    SNOMED
    415229000
    LOINC
    LP7528-5
    African American/African Heritage
    Description

    African American/African Heritage

    Data type

    boolean

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

    American Indian or Alaskan Native

    Data type

    boolean

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

    Asian - Central/South Asian Heritage

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0238696 (Central Asian)
    UMLS CUI [1,2]
    C1519427 (South Asian)
    Asian - East Asian Heritage
    Description

    Asian - East Asian Heritage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4540996 (East Asian ethnicity)
    Asian - Japanese Heritage
    Description

    Asian - Japanese Heritage

    Data type

    boolean

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

    Asian - South East Asian Heritage

    Data type

    boolean

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

    Native Hawaiian or Other Pacific Islander

    Data type

    boolean

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

    White - Arabic/North African Heritage

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0238604 (North African)
    UMLS CUI [1,2]
    C1552588 (Arabic <List Style>)
    White - White/Caucasian/European Heritage
    Description

    White - White/Caucasian/European Heritage

    Data type

    boolean

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

    Demographics

    1 forms
    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])
    Sex
    Code List
    Sex
    CL Item
    Male (m)
    CL Item
    female (f)
    Item
    Ethnicity
    integer
    C0015031 (UMLS CUI [1])
    Ethnicity
    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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