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ID

36014

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the AE form. It has to be filled in for all Sessions each for both Day 1 and Day 2.

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  1. 4/9/19 4/9/19 -
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GlaxoSmithKline

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April 9, 2019

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Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    English

    Adverse Events (AE) for Sessions

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject No.
    Description

    Subject No.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Panel ID
    Description

    Panel ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Visit type
    Description

    Visit type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Adverse event
    Description

    Adverse event

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Planned relative time
    Description

    Note: Tick "+2h and +6h" only for Day 1. "+16h" is for Day 2 mandatory.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Have any Adverse Events been observed/reported?
    Description

    If YES, please complete the "Adverse Event" form.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
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    Similar models

    Adverse Events (AE) for Sessions

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Session 1 day 1 (1)
    CL Item
    Session 1 day 2 (2)
    CL Item
    Session 2 day 1  (3)
    CL Item
    Session 2 day 2 (4)
    CL Item
    Session 3 day 1 (5)
    CL Item
    Session 3 day 2 (6)
    CL Item
    Session 4 day 1 (7)
    CL Item
    Session 4 day 2 (8)
    CL Item
    Session 5 day 1 (9)
    CL Item
    Session 5 day 2 (10)
    Item Group
    Adverse event
    C0877248 (UMLS CUI-1)
    Item
    Planned relative time
    integer
    C0439564 (UMLS CUI [1])
    Planned relative time
    Code List
    Planned relative time
    CL Item
    +2h (1)
    CL Item
    +6h (2)
    CL Item
    +16h (3)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Time
    Item
    Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Have any Adverse Events been observed/reported?
    text
    C0877248 (UMLS CUI [1])
    Adverse event observed
    Code List
    Have any Adverse Events been observed/reported?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Back to the top of the page 

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