ID

41072

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 (2)
  1. 6/19/20 6/19/20 -
  2. 6/19/20 6/19/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

June 19, 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
    Subject Number
    Descripción

    Subject Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Concomitant Medications
    Descripción

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Were any concomitant medications taken by the subject prior to dosing and/or during the study?
    Descripción

    If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Concomitant Medications
    Descripción

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Drug Name
    Descripción

    (Trade Name Preferred)

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2360065
    Unit Dose
    Descripción

    (eg.500mg)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0869039
    Units
    Descripción

    Units

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1519795
    Frequency
    Descripción

    (e.g.BID)

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3476109
    Concomitant Medication Route
    Descripción

    Concomitant Medication Route

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826730
    Reason for Concomitant Medication
    Descripción

    Reason for Concomitant Medication

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826696
    Concomitant Medication Start Date
    Descripción

    Concomitant Medication Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826734
    Concomitant Medication Start Time
    Descripción

    Concomitant Medication Start Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1301880
    Concomitant medication taken prior to study?
    Descripción

    Concomitant medication taken prior to study?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    Concomitant Medication Stop Date
    Descripción

    Concomitant Medication Stop Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826744
    Concomitant Medication Stop Time
    Descripción

    Concomitant Medication Stop Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C2826659
    Ongoing medication?
    Descripción

    Ongoing medication?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2826666
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    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 Medications
    C2347852 (UMLS CUI-1)
    Were any concomitant medications taken by the subject prior to dosing and/or during the study?
    Item
    Were any concomitant medications taken by the subject prior to dosing and/or during the study?
    boolean
    C2347852 (UMLS CUI [1])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1])
    Unit Dose
    Item
    Unit Dose
    float
    C0869039 (UMLS CUI [1])
    Item
    Units
    text
    C1519795 (UMLS CUI [1])
    Units
    Code List
    Units
    CL Item
    Tablet  (TAB)
    CL Item
    Microlitre  (MCL)
    CL Item
    Millilitre  (ML)
    CL Item
    Litre  (L)
    CL Item
    Microgram (MCG)
    CL Item
    Milligram (MG)
    CL Item
    Gram (G)
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    Frequency
    Code List
    Frequency
    CL Item
    1 x Daily (OD/QD)
    CL Item
    2 x Daily (BID)
    CL Item
    3 x Daily (TID)
    CL Item
    4 x Daily (QID)
    CL Item
    As required (PRN)
    Item
    Concomitant Medication Route
    text
    C2826730 (UMLS CUI [1])
    Concomitant Medication Route
    Code List
    Concomitant Medication Route
    CL Item
    Intramuscular (IM)
    CL Item
    Inhalation (IH)
    CL Item
    Intravenous (IV)
    CL Item
    Nasal (NS)
    CL Item
    Topical (TP)
    CL Item
    Oral (PO)
    CL Item
    Vaginal (VG)
    Reason for Concomitant Medication
    Item
    Reason for Concomitant Medication
    text
    C2826696 (UMLS CUI [1])
    Concomitant Medication Start Date
    Item
    Concomitant Medication Start Date
    date
    C2826734 (UMLS CUI [1])
    Concomitant Medication Start Time
    Item
    Concomitant Medication Start Time
    time
    C2347852 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Concomitant medication taken prior to study?
    Item
    Concomitant medication taken prior to study?
    boolean
    C2826667 (UMLS CUI [1])
    Concomitant Medication Stop Date
    Item
    Concomitant Medication Stop Date
    date
    C2826744 (UMLS CUI [1])
    Concomitant Medication Stop Time
    Item
    Concomitant Medication Stop Time
    time
    C2826659 (UMLS CUI [1])
    Ongoing medication?
    Item
    Ongoing medication?
    boolean
    C2826666 (UMLS CUI [1])
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