0 Evaluaciones
ID

32048

Descripción

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

Palabras clave

Versiones (1)
  1. 15-10-18 15-10-18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

15 oktober 2018

DOI

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Licencia

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

    Inglés

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

    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
    Vital SIgns
    Descripción

    Vital SIgns

    Alias
    UMLS CUI-1
    C0518766
    Date
    Descripción

    Date of examination of the vital signs

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826644
    Time
    Descripción

    Time of the examination of the vital signs

    Tipo de datos

    time

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

    Sitting

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure (diastolic)
    Descripción

    Sitting

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Descripción

    Heart rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/minute
    Alias
    UMLS CUI [1]
    C0018810
    beats/minute
    12-Lead ECG
    Descripción

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    Start date of ECG
    Descripción

    Start date of ECG

    Tipo de datos

    date

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

    Start time of ECG

    Tipo de datos

    time

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

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

    Tipo de datos

    text

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

    Laboratory Tests - Clinical Chemistry, Haematology

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

    Was a blood sample taken for the clinical laboratory tests?

    Tipo de datos

    text

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

    Date sample taken

    Tipo de datos

    date

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

    Pregnancy Test (Complete for Female Subjects Only)

    Alias
    UMLS CUI-1
    C0032976
    Date sample taken
    Descripción

    Date of pregnancy test

    Tipo de datos

    date

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

    Result of the pregnancy test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0427777
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    Similar models

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

    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])
    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)
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