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ID

32048

Beskrivning

This ODM file contains the form for documentation of the vital signs, the 12-lead ecg, the laboratory testing and the pregnancy test. To be assessed at follow-up 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

Nyckelord

Versioner (1)
  1. 2018-10-15 2018-10-15 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 oktober 2018

DOI

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Licens

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

    Engelsk

    Vital Signs, 12-Lead ECG, Laboratory Tests and Pregnancy Test (Follow-up Visit)

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Beskrivning

    Visit Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Vital SIgns
    Beskrivning

    Vital SIgns

    Alias
    UMLS CUI-1
    C0518766
    Date
    Beskrivning

    Date of examination of the vital signs

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2826644
    Time
    Beskrivning

    Time of the examination of the vital signs

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C2826762
    Blood pressure (systolic)
    Beskrivning

    Sitting

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure (diastolic)
    Beskrivning

    Sitting

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Beskrivning

    Heart rate

    Datatyp

    integer

    Måttenheter
    • beats/minute
    Alias
    UMLS CUI [1]
    C0018810
    beats/minute
    12-Lead ECG
    Beskrivning

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    Start date of ECG
    Beskrivning

    Start date of ECG

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0808070
    Start time of ECG
    Beskrivning

    Start time of ECG

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1301880
    Result of the ECG (check one)
    Beskrivning

    Complete additional ECG Abnormalities page if clinically significant abnormalities are present.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0438154
    UMLS CUI [1,2]
    C0430456
    Laboratory Tests - Clinical Chemistry, Haematology
    Beskrivning

    Laboratory Tests - Clinical Chemistry, Haematology

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-3
    C0018941
    Was a blood sample taken for the clinical laboratory tests?
    Beskrivning

    Was a blood sample taken for the clinical laboratory tests?

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0005834
    If Yes, Date sample taken
    Beskrivning

    Date sample taken

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Pregnancy Test (Complete for Female Subjects Only)
    Beskrivning

    Pregnancy Test (Complete for Female Subjects Only)

    Alias
    UMLS CUI-1
    C0032976
    Date sample taken
    Beskrivning

    Date of pregnancy test

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Result of the pregnancy test
    Beskrivning

    Result of the pregnancy test

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0427777
    Tillbaka till toppen

    Similar models

    Vital Signs, 12-Lead ECG, Laboratory Tests and Pregnancy Test (Follow-up Visit)

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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
    Vital SIgns
    C0518766 (UMLS CUI-1)
    Date of examination of the vital signs
    Item
    Date
    date
    C2826644 (UMLS CUI [1])
    Time of the examination of the vital signs
    Item
    Time
    time
    C2826762 (UMLS CUI [1])
    Systolic blood pressure
    Item
    Blood pressure (systolic)
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Blood pressure (diastolic)
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    Start date of ECG
    Item
    Start date of ECG
    date
    C0430456 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start time of ECG
    Item
    Start time of ECG
    time
    C0430456 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Item
    Result of the ECG (check one)
    text
    C0438154 (UMLS CUI [1,1])
    C0430456 (UMLS CUI [1,2])
    Result of the 12-Lead ECG
    Code List
    Result of the ECG (check one)
    CL Item
    Normal ([1])
    CL Item
    Abnormal - not clinically significant ([2])
    CL Item
    Abnormal - clinically significant ([3])
    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])
    Was a blood sample taken for the clinical laboratory tests?
    Code List
    Was a blood sample taken for the clinical laboratory tests?
    CL Item
    Yes ([Y])
    CL Item
    No ([N])
    Date sample taken
    Item
    If Yes, Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item Group
    Pregnancy Test (Complete for Female Subjects Only)
    C0032976 (UMLS CUI-1)
    Date of pregnancy test
    Item
    Date sample taken
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Result of the pregnancy test
    integer
    C0427777 (UMLS CUI [1])
    Result of the pregnancy test
    Code List
    Result of the pregnancy test
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    CL Item
    Not applicable (Not of childbearing potential) (3)
    Tillbaka till toppen 

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