ID

31898

Description

This ODM file contains the form to record the results of the pregnancy test. To be assessed at Day -1 of Period 1 and 2. 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

Keywords

Versions (1)
  1. 10/7/18 10/7/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 7, 2018

DOI

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License

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

    English

    Pregnancy Test

    1 forms  
    1. StudyEvent: ODM
      1. Pregnancy Test
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Visit Type
    Description

    Visit Type

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3641100
    Subject identifier
    Description

    Subject identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Pregnancy Test (Complete for Female Subjects Only)
    Description

    Pregnancy Test (Complete for Female Subjects Only)

    Alias
    UMLS CUI-1
    C0032976
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Results
    Description

    Results of Pregnancy Test

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1274040
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    Similar models

    Pregnancy Test

    1 forms
    1. StudyEvent: ODM
      1. Pregnancy Test
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Item
    Visit Type
    integer
    C3641100 (UMLS CUI [1])
    Visit Type
    Code List
    Visit Type
    CL Item
    Day-1 of Period 1 (1)
    CL Item
    Day-1 of Period 2 (2)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Pregnancy Test (Complete for Female Subjects Only)
    C0032976 (UMLS CUI-1)
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item
    Results
    integer
    C0032976 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Results of Pregnancy Test
    Code List
    Results
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    CL Item
    Not applicable (Not of childbearing potential) (3)
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