ID

40755

Description

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Keywords

  1. 5/8/20 5/8/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 8, 2020

DOI

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License

Creative Commons BY-NC 4.0

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    Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

    PK Blood Sampling

    1. StudyEvent: ODM
      1. PK Blood Sampling
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Description

    Centre Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    PK Blood Sampling
    Description

    PK Blood Sampling

    Alias
    UMLS CUI-1
    C0005834
    UMLS CUI-2
    C0031327
    Time relative to start of dose
    Description

    Time relative to start of dose

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0040223
    UMLS CUI [2,1]
    C3174092
    UMLS CUI [2,2]
    C0439659
    PK Blood Sampling - Date
    Description

    PK Blood Sampling - Date

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031327
    UMLS CUI [2]
    C0011008
    PK Blood Sampling - Actual Time
    Description

    PK Blood Sampling - Actual Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031327
    UMLS CUI [2]
    C0040223
    PK Blood Sample Taken?
    Description

    PK Blood Sample Taken?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031327
    PK Blood Sampling
    Description

    PK Blood Sampling

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031327
    UMLS CUI [2]
    C0947611

    Similar models

    PK Blood Sampling

    1. StudyEvent: ODM
      1. PK Blood Sampling
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Item Group
    PK Blood Sampling
    C0005834 (UMLS CUI-1)
    C0031327 (UMLS CUI-2)
    Item
    Time relative to start of dose
    integer
    C0040223 (UMLS CUI [1])
    C3174092 (UMLS CUI [2,1])
    C0439659 (UMLS CUI [2,2])
    Code List
    Time relative to start of dose
    CL Item
    Pre-dose (1)
    CL Item
    +0.25 hrs (2)
    CL Item
    +0.5 hrs (3)
    CL Item
    +1 hr (4)
    CL Item
    +1.5 hrs (5)
    CL Item
    +2 hrs (6)
    CL Item
    +3 hrs (7)
    CL Item
    +4 hrs (8)
    CL Item
    +6 hrs (9)
    CL Item
    +8 hrs (10)
    CL Item
    +12 hrs (11)
    CL Item
    +24 hrs (12)
    PK Blood Sampling - Date
    Item
    PK Blood Sampling - Date
    datetime
    C0005834 (UMLS CUI [1,1])
    C0031327 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [2])
    PK Blood Sampling - Actual Time
    Item
    PK Blood Sampling - Actual Time
    time
    C0005834 (UMLS CUI [1,1])
    C0031327 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [2])
    PK Blood Sample Taken?
    Item
    PK Blood Sample Taken?
    boolean
    C0005834 (UMLS CUI [1,1])
    C0031327 (UMLS CUI [1,2])
    PK Blood Sampling
    Item
    PK Blood Sampling
    text
    C0005834 (UMLS CUI [1,1])
    C0031327 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [2])

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