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ID

40874

Description

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

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Versions (1)
  1. 29/05/2020 29/05/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

29 mai 2020

DOI

Pour une demande vous connecter.

Licence

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

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    Concomitant Medication

    1 Formulaires  
    1. StudyEvent: ODM
      1. Concomitant Medication
    Administrative
    Description

    Administrative

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

    Subject Number

    Type de données

    text

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

    Concomitant Medication

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

    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.

    Type de données

    boolean

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

    Concomitant Medication

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

    (Trade Name Preferred)

    Type de données

    text

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

    (eg.500mg)

    Type de données

    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
    Description

    (e.g.BID,PRN)

    Type de données

    text

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

    Concomitant Medication Route

    Type de données

    text

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

    Concomitant Medication Indication

    Type de données

    text

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

    Concomitant Medication Start Date/Time

    Type de données

    datetime

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

    Concomitant Medication End Date/Time

    Type de données

    datetime

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

    Concomitant Medication continuing at end of Study?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
    Retour au début de la page

    Similar models

    Concomitant Medication

    1 Formulaires
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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