0 Evaluaciones
ID

44237

Descripción

This ODM-file contains the data collection questions for demographics and childbearing potential. To be assessed at screening. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Palabras clave

Versiones (2)
  1. 2018-10-12 2018-10-12 -
  2. 2021-09-20 2021-09-20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 september 2021

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet 106396

    Inglés

    Demographics and Childbearing Potential

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descripción

    Subject Identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Descripción

    Visit Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Centre Number
    Descripción

    Centre Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Demography
    Descripción

    Demography

    Alias
    UMLS CUI-1
    C0011298
    Date of birth
    Descripción

    Date of birth

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Descripción

    Sex

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0079399
    Ethnicity: Pick one:
    Descripción

    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, pick Not Hispanic or Latino. • Not Hispanic or Latino Neither Hispanic or Latino

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0015031
    Geographic Ancestry: African American/African Heritage
    Descripción

    A person having origins in any of the black racial groups of Africa

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0085756
    UMLS CUI [2]
    C0027567
    Geographic Ancestry: American Indian or Alaskan Native
    Descripción

    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 de datos

    boolean

    Alias
    UMLS CUI [1]
    C1515945
    Geographic Ancestry: Asian - Central/South Asian Heritage
    Descripción

    A person having origins in Central Asia (Kazakstan, Kyrgystan, Tajikstan, Turkmenistan and Uzbekistan) and Indian Subcontinent (India, Pakistan, Bangladesh and Sri Lanka)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0238696
    UMLS CUI [2]
    C1519427
    Geographic Ancestry: Asian - East Asian Heritage
    Descripción

    A person having origins in China, Korea

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C4540996
    Geographic Ancestry: Asian - Japanese Heritage
    Descripción

    A person having origins in Japan

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1556094
    Geographic Ancestry: Asian - South East Asia Heritage
    Descripción

    A person having origins in Malaysia, the Philippines, Indonesia, Thailand, Vietnam, Laos, Burma or Cambodia

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0238697
    Geographic Ancestry: Native Hawaiian or Other Pacific Islander
    Descripción

    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 de datos

    boolean

    Alias
    UMLS CUI [1]
    C1513907
    Geographic Ancestry: White - Arabic/North African Heritage
    Descripción

    A person having origins in any of the original peoples of Middle East or North Africa

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0238604
    UMLS CUI [2]
    C0026068
    Geographic Ancestry: White - White/Caucasian European Heritage
    Descripción

    A person having origins in any of the original peoples of Europe

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0043157
    Child-bearing Potential (Complete for Female Subjects Only)
    Descripción

    Child-bearing Potential (Complete for Female Subjects Only)

    Alias
    UMLS CUI-1
    C3831118
    Tick one:
    Descripción

    Child-bearing Potential (Complete for Female Subjects Only) Definitions • Post-menopausal Women who have completed menopause at least one year ago. • Sterile Pre-menopausal women who cannot conceive children. (This category includes women who have become sterile through surgical procedures such as tubal ligation. Do not include post-menopausal women in this category.) • Potentially able to bear children Women of child-bearing age who are not sterile. Note: If the subject is sterile and is not of child-bearing age, then ‘post-menopausal’ will be the best choice and should be picked. If the subject is sterile and does not know if she is post-menopausal and is less than 62 years of age, then she is of child-bearing age and ‘sterile’ should be picked.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C3831118
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    Similar models

    Demographics and Childbearing Potential

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    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)
    C1706180 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Female (F)
    C0086287 (UMLS CUI-1)
    (Comment:en)
    Item
    Ethnicity: Pick one:
    integer
    C0015031 (UMLS CUI [1])
    Ethnicity: Hispanic or Latino, Not Hispanic or Latino
    Code List
    Ethnicity: Pick one:
    CL Item
    Hispanic or Latino (1)
    C0086409 (UMLS CUI-1)
    C0086528 (UMLS CUI-3)
    (Comment:en)
    CL Item
    Not Hispanic or Latino (2)
    C1518424 (UMLS CUI-1)
    (Comment:en)
    Geographic Ancestry: African American/African Heritage
    Item
    Geographic Ancestry: African American/African Heritage
    boolean
    C0085756 (UMLS CUI [1])
    C0027567 (UMLS CUI [2])
    Geographic Ancestry: American Indian or Alaskan Native
    Item
    Geographic Ancestry: American Indian or Alaskan Native
    boolean
    C1515945 (UMLS CUI [1])
    Geographic Ancestry: Asian - Central/South Asian Heritage
    Item
    Geographic Ancestry: Asian - Central/South Asian Heritage
    boolean
    C0238696 (UMLS CUI [1])
    C1519427 (UMLS CUI [2])
    Geographic Ancestry: Asian - East Asian Heritage
    Item
    Geographic Ancestry: Asian - East Asian Heritage
    boolean
    C4540996 (UMLS CUI [1])
    Geographic Ancestry: Asian - Japanese Heritage
    Item
    Geographic Ancestry: Asian - Japanese Heritage
    boolean
    C1556094 (UMLS CUI [1])
    Geographic Ancestry: Asian - South East Asia Heritage
    Item
    Geographic Ancestry: Asian - South East Asia Heritage
    boolean
    C0238697 (UMLS CUI [1])
    Geographic Ancestry: Native Hawaiian or Other Pacific Islander
    Item
    Geographic Ancestry: Native Hawaiian or Other Pacific Islander
    boolean
    C1513907 (UMLS CUI [1])
    Geographic Ancestry: White - Arabic/North African Heritage
    Item
    Geographic Ancestry: White - Arabic/North African Heritage
    boolean
    C0238604 (UMLS CUI [1])
    C0026068 (UMLS CUI [2])
    Geographic Ancestry: White - White/Caucasian European Heritage
    Item
    Geographic Ancestry: White - White/Caucasian European Heritage
    boolean
    C0043157 (UMLS CUI [1])
    Item Group
    Child-bearing Potential (Complete for Female Subjects Only)
    C3831118 (UMLS CUI-1)
    Item
    Tick one:
    integer
    C3831118 (UMLS CUI [1])
    Child-bearing potential (complete for female subjects only)
    Code List
    Tick one:
    CL Item
    Post-menopausal (2)
    C0021359 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Sterile (of child-bearing age) (3)
    C3831118 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Potentially able to bear children (4)
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