0 Evaluaciones
ID

40874

Descripción

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Palabras clave

Versiones (1)
  1. 29/5/20 29/5/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

29 de mayo de 2020

DOI

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Licencia

Creative Commons BY-NC 4.0
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    Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

    Inglés

    Concomitant Medication

    1 formularios  
    1. StudyEvent: ODM
      1. Concomitant Medication
    Administrative
    Descripción

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Descripción

    Subject Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Concomitant Medication
    Descripción

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Are there any concomitant medication CHANGES since the start of the study?
    Descripción

    If ’YES’, please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Events Form, utilizing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0443172 (Changed status)
    SNOMED
    263703002
    Concomitant Medication
    Descripción

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Drug Name
    Descripción

    (Trade Name Preferred)

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    SINGLE Dose/Unit
    Descripción

    (eg.500mg)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1960417 (Single dose characteristic)
    SNOMED
    426146003
    UMLS CUI [1,2]
    C0869039 (Unit dose)
    SNOMED
    408102007
    Frequency of this Dose
    Descripción

    (e.g.BID,PRN)

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3476109 (Medication frequency)
    LOINC
    LP149758-7
    Concomitant Medication Route
    Descripción

    Concomitant Medication Route

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826730 (Concomitant Medication Route of Administration)
    Concomitant Medication Indication
    Descripción

    Concomitant Medication Indication

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826696 (Concomitant Medication Use Indication)
    Concomitant Medication Start Date/Time
    Descripción

    Concomitant Medication Start Date/Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1]
    C2826825 (Concomitant Medication Use Start Date Time)
    Concomitant Medication End Date/Time
    Descripción

    Concomitant Medication End Date/Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1]
    C2826815 (Concomitant Medication Use End Date Time)
    Concomitant Medication continuing at end of Study?
    Descripción

    Concomitant Medication continuing at end of Study?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
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    Similar models

    Concomitant Medication

    1 formularios
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Are there any concomitant medication CHANGES since the start of the study?
    Item
    Are there any concomitant medication CHANGES since the start of the study?
    boolean
    C2347852 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1])
    SINGLE Dose/Unit
    Item
    SINGLE Dose/Unit
    text
    C1960417 (UMLS CUI [1,1])
    C0869039 (UMLS CUI [1,2])
    Frequency of this Dose
    Item
    Frequency of this Dose
    text
    C3476109 (UMLS CUI [1])
    Concomitant Medication Route
    Item
    Concomitant Medication Route
    text
    C2826730 (UMLS CUI [1])
    Concomitant Medication Indication
    Item
    Concomitant Medication Indication
    text
    C2826696 (UMLS CUI [1])
    Concomitant Medication Start Date/Time
    Item
    Concomitant Medication Start Date/Time
    datetime
    C2826825 (UMLS CUI [1])
    Concomitant Medication End Date/Time
    Item
    Concomitant Medication End Date/Time
    datetime
    C2826815 (UMLS CUI [1])
    Concomitant Medication continuing at end of Study?
    Item
    Concomitant Medication continuing at end of Study?
    boolean
    C2826666 (UMLS CUI [1])
    Volver a la parte superior de la página 

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