0 Evaluaciones

ID

33501

Descripción

Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

Palabras clave

  1. 8/11/18 8/11/18 -
  2. 11/12/18 11/12/18 -
  3. 11/12/18 11/12/18 -
Titular de derechos de autor

GSK group of companies

Subido en

11 de diciembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0

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    A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904

    12-lead ECG Form

    1. StudyEvent: ODM
      1. 12-lead ECG Form
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Site
    Descripción

    Site

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2825164
    Patient
    Descripción

    Patient

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1299487
    Patient Number
    Descripción

    Patient Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1300638
    Screening ECG
    Descripción

    Screening ECG

    Alias
    UMLS CUI-1
    C1623258
    UMLS CUI-2
    C0220908
    Date of ECG
    Descripción

    Date of ECG

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826640
    Time of ECG
    Descripción

    Time of ECG

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    PR Interval
    Descripción

    PR Interval

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS Duration
    Descripción

    QRS Duration

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Descripción

    Uncorrected QT Interval

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTc Interval
    Descripción

    QTc Interval

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0489625
    msec
    Result of the ECG
    Descripción

    Result of the ECG

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0438154

    Similar models

    12-lead ECG Form

    1. StudyEvent: ODM
      1. 12-lead ECG Form
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Patient
    Item
    Patient
    text
    C1299487 (UMLS CUI [1])
    Patient Number
    Item
    Patient Number
    integer
    C0030705 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Item Group
    Screening ECG
    C1623258 (UMLS CUI-1)
    C0220908 (UMLS CUI-2)
    Date of ECG
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    PR Interval
    Item
    PR Interval
    float
    C0429087 (UMLS CUI [1])
    QRS Duration
    Item
    QRS Duration
    float
    C0429025 (UMLS CUI [1])
    Uncorrected QT Interval
    Item
    Uncorrected QT Interval
    float
    C1287082 (UMLS CUI [1])
    QTc Interval
    Item
    QTc Interval
    float
    C0489625 (UMLS CUI [1])
    Item
    Result of the ECG
    text
    C0438154 (UMLS CUI [1])
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE) (3)
    CL Item
    No result (not available) (4)

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