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31860

Description

This ODM-file contains a form to fill in findings of the laboratory, serology and pregnancy testing. To be assessed at the screening visit. 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 (2)
  1. 10/3/18 10/3/18 -
  2. 10/4/18 10/4/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 4, 2018

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

    English

    Laboratory Tests, Serology and Pregnancy Test

    1 forms  
    Administrative Data
    Description

    Administrative Data

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

    Subject Identifier

    Data type

    text

    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
    Laboratory Tests - Clinical Chemistry, Haematology
    Description

    Laboratory Tests - Clinical Chemistry, Haematology

    Alias
    UMLS CUI-1
    C0008000 (Chemistry, Clinical)
    UMLS CUI-3
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    Was a blood sample taken for the clinical laboratory tests?
    Description

    Blood sample

    Data type

    text

    Alias
    UMLS CUI [1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    If a blood sample was taken for the clinical laboratory tests: Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Serology
    Description

    Serology

    Alias
    UMLS CUI-1
    C0036743 (Serologic tests)
    SNOMED
    68793005
    LOINC
    MTHU008384
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    HIV antibody
    Description

    If positive, exclude subject from the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0920548 (HIV antibody positive)
    Hepatitis B surface antigen
    Description

    If positive, exclude subject from the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0019168 (Hepatitis B Surface Antigens)
    SNOMED
    22290004
    LOINC
    LP38331-2
    Hepatitis C antibody
    Description

    If positive, exclude subject from the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0201487 (Hepatitis C antibody measurement)
    SNOMED
    64411004
    Pregnancy Test (Complete for Female Subjects Only)
    Description

    Pregnancy Test (Complete for Female Subjects Only)

    Alias
    UMLS CUI-1
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Results
    Description

    Results of the pregnancy test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0427777 (Pregnancy test finding)
    SNOMED
    250421003
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    Similar models

    Laboratory Tests, Serology and Pregnancy Test

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Item Group
    Laboratory Tests - Clinical Chemistry, Haematology
    C0008000 (UMLS CUI-1)
    C0018941 (UMLS CUI-3)
    Item
    Was a blood sample taken for the clinical laboratory tests?
    text
    C0005834 (UMLS CUI [1])
    Blood sample
    Code List
    Was a blood sample taken for the clinical laboratory tests?
    CL Item
    Yes (Y)
    (Comment:en)
    CL Item
    No (N)
    (Comment:en)
    Date sample taken
    Item
    If a blood sample was taken for the clinical laboratory tests: Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item Group
    Serology
    C0036743 (UMLS CUI-1)
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item
    HIV antibody
    integer
    C0920548 (UMLS CUI [1])
    Results of the pregnancy test
    Code List
    HIV antibody
    CL Item
    Positive (1)
    (Comment:en)
    CL Item
    Negative (2)
    (Comment:en)
    Item
    Hepatitis B surface antigen
    integer
    C0019168 (UMLS CUI [1])
    Results of the pregnancy test
    Code List
    Hepatitis B surface antigen
    CL Item
    Positive (1)
    (Comment:en)
    CL Item
    Negative (2)
    (Comment:en)
    Item
    Hepatitis C antibody
    integer
    C0201487 (UMLS CUI [1])
    Results of the pregnancy test
    Code List
    Hepatitis C antibody
    CL Item
    Positive (1)
    (Comment:en)
    CL Item
    Negative (2)
    (Comment:en)
    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
    C0427777 (UMLS CUI [1])
    Results of the pregnancy test
    Code List
    Results
    CL Item
    Positive (1)
    (Comment:en)
    CL Item
    Negative (2)
    (Comment:en)
    Back to the top of the page 

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