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ID

31908

Description

This ODM file contains the form to document the telemetry. 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

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Versions (2)
  1. 10/7/18 10/7/18 -
  2. 10/8/18 10/8/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 8, 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

    Telemetry

    1 forms  
    1. StudyEvent: ODM
      1. Telemetry
    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
    Visit Type
    Description

    Visit Type

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3641100 (Subject Visit Type)
    Telemetry
    Description

    Telemetry

    Alias
    UMLS CUI-1
    C0039451 (Telemetry)
    Was continuous telemetry monitoring completed?
    Description

    Continuous telemetry monitoring

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039451 (Telemetry)
    UMLS CUI [1,2]
    C0549178 (Continuous)
    SNOMED
    255238004
    LOINC
    LA16902-1
    If Yes, Start time:
    Description

    Telemetry start time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0039451 (Telemetry)
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    If Yes, Stop time:
    Description

    Telemetry stop time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0039451 (Telemetry)
    UMLS CUI [1,2]
    C1522314 (End Time)
    SNOMED
    397898000
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    Similar models

    Telemetry

    1 forms
    1. StudyEvent: ODM
      1. Telemetry
    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
    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)
    Item Group
    Telemetry
    C0039451 (UMLS CUI-1)
    Item
    Was continuous telemetry monitoring completed?
    text
    C0039451 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Continuous telemetry monitoring
    Code List
    Was continuous telemetry monitoring completed?
    CL Item
    Yes (Y)
    (Comment:en)
    CL Item
    No (N)
    (Comment:en)
    Telemetry start time
    Item
    If Yes, Start time:
    time
    C0039451 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Telemetry stop time
    Item
    If Yes, Stop time:
    time
    C0039451 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
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