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ID

34023

Beschrijving

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

Trefwoorden

  1. 09-11-18 09-11-18 -
  2. 11-01-19 11-01-19 -
Houder van rechten

GSK group of companies

Geüploaded op

11 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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

    Follow-Up: Pregnancy Information

    Administrative data
    Beschrijving

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Site
    Beschrijving

    Site

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2825164
    Patient
    Beschrijving

    Patient

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1299487
    Patient Number
    Beschrijving

    Patient Number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1300638
    Pregnancy Information
    Beschrijving

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did the subject become pregnant during the study?
    Beschrijving

    For each study session Pregnancy test should be done at Predose

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0008976
    If YES, complete the paper Pregnancy Notification form
    Beschrijving

    If YES, complete the paper Pregnancy Notification form

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0008976
    Pregnancy Information Part 2
    Beschrijving

    Pregnancy Information Part 2

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did a female partner of the male subject become pregnant during the study?
    Beschrijving

    If YES, complete the paper Pregnancy Notification form

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0682323
    UMLS CUI [1,3]
    C0008976

    Similar models

    Follow-Up: Pregnancy Information

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Did the subject become pregnant during the study?
    Item
    Did the subject become pregnant during the study?
    boolean
    C0032961 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    If YES, complete the paper Pregnancy Notification form
    Item
    If YES, complete the paper Pregnancy Notification form
    text
    C0032961 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Item Group
    Pregnancy Information Part 2
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did a female partner of the male subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1,1])
    C0682323 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Code List
    Did a female partner of the male subject become pregnant during the study?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Not Applicable (Check Not Applicable if female partner not of childbearing or no female partner) (3)

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