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ID

39421

Description

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Keywords

Versions (2)
  1. 12/6/19 12/6/19 -
  2. 1/9/20 1/9/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 9, 2020

DOI

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License

Creative Commons BY-NC 3.0
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    Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532)

    English

    Baseline - IP Compliance; Pharmacogenetic (PGx) Research

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Study Name
    Description

    Study Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348560
    Subject ID
    Description

    Subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Study Site
    Description

    Study Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164
    Investigational Product - Study drug dispensed
    Description

    Investigational Product - Study drug dispensed

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0947323
    Was study drug dispensed?
    Description

    Was study drug dispensed?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0947323
    Investigational Product #
    Description

    Investigational Product #

    Data type

    text

    Alias
    UMLS CUI [1]
    C0304229
    Date investigational product dispensed
    Description

    Date investigational product dispensed

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0947323
    UMLS CUI [1,3]
    C0011008
    Investigational Product - Total # tablets dispensed
    Description

    Investigational Product - Total # tablets dispensed

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0805077
    Investigational Product - Additional bottle(s) disepensed?
    Description

    Investigational Product - Additional bottle(s) disepensed?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0947323
    UMLS CUI [1,3]
    C0179376
    UMLS CUI [1,4]
    C1524062
    Additional bottle(s) dispensed
    Description

    Additional bottle(s) dispensed

    Alias
    UMLS CUI-1
    C0947323
    UMLS CUI-2
    C0179376
    UMLS CUI-3
    C1524062
    Additional bottle(s) dispensed - Sequence Number
    Description

    Additional bottle(s) dispensed - Sequence Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0947323
    UMLS CUI [1,2]
    C0179376
    UMLS CUI [1,3]
    C1524062
    UMLS CUI [2]
    C2348184
    Additional bottle(s) dispensed - Investigational Product #
    Description

    Additional bottle(s) dispensed - Investigational Product #

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0947323
    UMLS CUI [1,2]
    C0179376
    UMLS CUI [1,3]
    C1524062
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C0237753
    Additional bottle(s) dispensed - Date disepensed
    Description

    Additional bottle(s) dispensed - Date disepensed

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0947323
    UMLS CUI [1,2]
    C0179376
    UMLS CUI [1,3]
    C1524062
    UMLS CUI [2,1]
    C0947323
    UMLS CUI [2,2]
    C0011008
    Additional bottle(s) dispensed - Total # tablets dispensed
    Description

    Additional bottle(s) dispensed - Total # tablets dispensed

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0947323
    UMLS CUI [1,2]
    C0179376
    UMLS CUI [1,3]
    C1524062
    UMLS CUI [2]
    C0805077
    Current investigational product level
    Description

    Current investigational product level

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0441889
    UMLS CUI-3
    C0521116
    Current investigational product level
    Description

    Current investigational product level

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0441889
    UMLS CUI [1,3]
    C0521116
    L-Dopa medication
    Description

    L-Dopa medication

    Alias
    UMLS CUI-1
    C0023570
    L-dopa dose
    Description

    L-dopa dose

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0023570
    UMLS CUI [1,2]
    C0178602
    mg
    L-dopa release
    Description

    L-dopa release

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0023570
    UMLS CUI [1,2]
    C0391871
    Controlled release amt
    Description

    Controlled release amt

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C1707506
    UMLS CUI [1,2]
    C1561574
    mg
    Immediate release amt
    Description

    Immediate release amt

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C1708470
    UMLS CUI [1,2]
    C1561574
    mg
    Was L-dopa dose reduced?
    Description

    Was L-dopa dose reduced?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0023570
    UMLS CUI [1,2]
    C1707814
    Date L-dopa dose reduced
    Description

    Date L-dopa dose reduced

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0023570
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0011008
    Pharmacogenetic Research
    Description

    Pharmacogenetic Research

    Alias
    UMLS CUI-1
    C0031325
    Has informed consent been obtained for PGx research?
    Description

    Has informed consent been obtained for PGx research?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    Date of PGx consent
    Description

    Date of PGx consent

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    Has sample been collected for PGx research?
    Description

    Has sample been collected for PGx research?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C2347500
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Select reason
    Description

    Select reason

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0566251
    Specify other reason
    Description

    Specify other reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Has subject withdrawn consent for PGx research?
    Description

    Has subject withdrawn consent for PGx research?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C0031325
    Date PGx consent withdrawn
    Description

    Date PGx consent withdrawn

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    Has request been made for PGx sample destruction?
    Description

    Has request been made for PGx sample destruction?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    UMLS CUI [1,4]
    C1272683
    Enter the reason for request for sample destruction
    Description

    Enter the reason for request for sample destruction

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C0392360
    Specify other reason for request for sample destruction
    Description

    Specify other reason for request for sample destruction

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C0392360
    UMLS CUI [1,5]
    C0205394
    UMLS CUI [1,6]
    C2348235
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    Similar models

    Baseline - IP Compliance; Pharmacogenetic (PGx) Research

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Study Name
    Item
    Study Name
    text
    C2348560 (UMLS CUI [1])
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Study Site
    Item
    Study Site
    text
    C2825164 (UMLS CUI [1])
    Item Group
    Investigational Product - Study drug dispensed
    C0304229 (UMLS CUI-1)
    C0947323 (UMLS CUI-2)
    Was study drug dispensed?
    Item
    Was study drug dispensed?
    boolean
    C0304229 (UMLS CUI [1,1])
    C0947323 (UMLS CUI [1,2])
    Investigational Product #
    Item
    Investigational Product #
    text
    C0304229 (UMLS CUI [1])
    Date investigational product dispensed
    Item
    Date investigational product dispensed
    date
    C0304229 (UMLS CUI [1,1])
    C0947323 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Investigational Product - Total # tablets dispensed
    Item
    Investigational Product - Total # tablets dispensed
    integer
    C0304229 (UMLS CUI [1,1])
    C0805077 (UMLS CUI [1,2])
    Investigational Product - Additional bottle(s) disepensed?
    Item
    Investigational Product - Additional bottle(s) disepensed?
    boolean
    C0304229 (UMLS CUI [1,1])
    C0947323 (UMLS CUI [1,2])
    C0179376 (UMLS CUI [1,3])
    C1524062 (UMLS CUI [1,4])
    Item Group
    Additional bottle(s) dispensed
    C0947323 (UMLS CUI-1)
    C0179376 (UMLS CUI-2)
    C1524062 (UMLS CUI-3)
    Additional bottle(s) dispensed - Sequence Number
    Item
    Additional bottle(s) dispensed - Sequence Number
    integer
    C0947323 (UMLS CUI [1,1])
    C0179376 (UMLS CUI [1,2])
    C1524062 (UMLS CUI [1,3])
    C2348184 (UMLS CUI [2])
    Additional bottle(s) dispensed - Investigational Product #
    Item
    Additional bottle(s) dispensed - Investigational Product #
    integer
    C0947323 (UMLS CUI [1,1])
    C0179376 (UMLS CUI [1,2])
    C1524062 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [2,1])
    C0237753 (UMLS CUI [2,2])
    Additional bottle(s) dispensed - Date disepensed
    Item
    Additional bottle(s) dispensed - Date disepensed
    date
    C0947323 (UMLS CUI [1,1])
    C0179376 (UMLS CUI [1,2])
    C1524062 (UMLS CUI [1,3])
    C0947323 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    Additional bottle(s) dispensed - Total # tablets dispensed
    Item
    Additional bottle(s) dispensed - Total # tablets dispensed
    integer
    C0947323 (UMLS CUI [1,1])
    C0179376 (UMLS CUI [1,2])
    C1524062 (UMLS CUI [1,3])
    C0805077 (UMLS CUI [2])
    Item Group
    Current investigational product level
    C0304229 (UMLS CUI-1)
    C0441889 (UMLS CUI-2)
    C0521116 (UMLS CUI-3)
    Item
    Current investigational product level
    integer
    C0304229 (UMLS CUI [1,1])
    C0441889 (UMLS CUI [1,2])
    C0521116 (UMLS CUI [1,3])
    Current investigational product level
    Code List
    Current investigational product level
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    Item Group
    L-Dopa medication
    C0023570 (UMLS CUI-1)
    L-dopa dose
    Item
    L-dopa dose
    float
    C0023570 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Item
    L-dopa release
    integer
    C0023570 (UMLS CUI [1,1])
    C0391871 (UMLS CUI [1,2])
    L-dopa release
    Code List
    L-dopa release
    CL Item
    Controlled-release (prolonged release) (1)
    CL Item
    Immediate-release (conventional release) (2)
    CL Item
    Both (3)
    Controlled release amt
    Item
    Controlled release amt
    float
    C1707506 (UMLS CUI [1,1])
    C1561574 (UMLS CUI [1,2])
    Immediate release amt
    Item
    Immediate release amt
    float
    C1708470 (UMLS CUI [1,1])
    C1561574 (UMLS CUI [1,2])
    Item
    Was L-dopa dose reduced?
    integer
    C0023570 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    Was L-dopa dose reduced?
    Code List
    Was L-dopa dose reduced?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    half tablet (3)
    CL Item
    whole tablet (4)
    Date L-dopa dose reduced
    Item
    Date L-dopa dose reduced
    date
    C0023570 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Pharmacogenetic Research
    C0031325 (UMLS CUI-1)
    Has informed consent been obtained for PGx research?
    Item
    Has informed consent been obtained for PGx research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Date of PGx consent
    Item
    Date of PGx consent
    date
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Has sample been collected for PGx research?
    Item
    Has sample been collected for PGx research?
    boolean
    C0005834 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item
    Select reason
    integer
    C0566251 (UMLS CUI [1])
    Select reason
    Code List
    Select reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigato (2)
    CL Item
    Other (3)
    Specify other reason
    Item
    Specify other reason
    text
    C0566251 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Has subject withdrawn consent for PGx research?
    Item
    Has subject withdrawn consent for PGx research?
    boolean
    C1707492 (UMLS CUI [1,1])
    C0031325 (UMLS CUI [1,2])
    Date PGx consent withdrawn
    Item
    Date PGx consent withdrawn
    date
    C1707492 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Has request been made for PGx sample destruction?
    Item
    Has request been made for PGx sample destruction?
    boolean
    C2347500 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    C1272683 (UMLS CUI [1,4])
    Item
    Enter the reason for request for sample destruction
    integer
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    Enter the reason for request for sample destruction
    Code List
    Enter the reason for request for sample destruction
    CL Item
    Subject withdrew consent for PG (1)
    CL Item
    Other (2)
    Specify other reason for request for sample destruction
    Item
    Specify other reason for request for sample destruction
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [1,5])
    C2348235 (UMLS CUI [1,6])
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