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44255

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Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Phase: phase 3 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

Nyckelord

Versioner (2)
  1. 2019-02-19 2019-02-19 -
  2. 2021-09-20 2021-09-20 -
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GlaxoSmithKline

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20 september 2021

DOI

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Creative Commons BY-NC 3.0
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    Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

    Engelsk

    Ambulatory Blood Pressuure Monitoring Diary; Equipment Request

    1 Formulär  
    When dispensed?
    Beskrivning

    When dispensed?

    Alias
    UMLS CUI-1
    C1880359 (Dispense (Activity))
    Dispensed at the End of which Week Visit?
    Beskrivning

    Dispensed at the End of which Week Visit?

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1880359 (Dispense (Activity))
    UMLS CUI [1,2]
    C0545082 (Visit)
    Administrative
    Beskrivning

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Doctor’s Name:
    Beskrivning

    Doctor’s Name:

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2361125 (Attending physician name)
    LOINC
    MTHU028124
    Telephone Number:
    Beskrivning

    Telephone Number:

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1515258 (Telephone Number)
    SNOMED
    734005006
    LOINC
    LP6871-0
    Study Contact:
    Beskrivning

    Study Contact:

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0337611 (contact person)
    SNOMED
    70862002
    Ambulatory Blood Pressure Monitoring Diary
    Beskrivning

    Ambulatory Blood Pressure Monitoring Diary

    Alias
    UMLS CUI-1
    C0430452 (Ambulatory blood pressure recording (procedure))
    SNOMED
    164783007
    Date and time of dose:
    Beskrivning

    Date and time of dose:

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C1986447 (undefined)
    Date of Assessment:
    Beskrivning

    Date of Assessment:

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Blood Pressure Measurement
    Beskrivning

    Blood Pressure Measurement

    Alias
    UMLS CUI-1
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    Time of Blood Pressure Measurement
    Beskrivning

    Time of Blood Pressure Measurement

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Activity at time of Blood Pressure Measurement
    Beskrivning

    Check one activity level for each time point

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0005824 (Blood pressure determination)
    SNOMED
    46973005
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,3]
    C0026606 (Physical activity)
    SNOMED
    48761009
    LOINC
    LP34367-0
    Equipment Request
    Beskrivning

    Equipment Request

    Alias
    UMLS CUI-1
    C0014672 (Equipment)
    SNOMED
    246137000
    LOINC
    LP264340-3
    UMLS CUI-2
    C1272683 (Request - action)
    SNOMED
    385644000
    Date of Request:
    Beskrivning

    Date of Request:

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1272683 (Request - action)
    SNOMED
    385644000
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Investigator’s name:
    Beskrivning

    Investigator’s name:

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
    Site Number:
    Beskrivning

    Site Number:

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C2825164 (Study Site)
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Requestor’s name:
    Beskrivning

    Requestor’s name:

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1272683 (Request - action)
    SNOMED
    385644000
    UMLS CUI [1,2]
    C0027365 (Name)
    SNOMED
    703503000
    LOINC
    LP72974-6
    Requestor’s phone number:
    Beskrivning

    Requestor’s phone number:

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1272683 (Request - action)
    SNOMED
    385644000
    UMLS CUI [1,2]
    C1515258 (Telephone Number)
    SNOMED
    734005006
    LOINC
    LP6871-0
    Number of ABP 90207 monitors:
    Beskrivning

    Number of ABP 90207 monitors:

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    UMLS CUI [1,2]
    C0181904 (Monitor Device)
    SNOMED
    13288007
    Cuff Size(s):
    Beskrivning

    Cuff Size(s):

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0489480 (cuff size)
    Time Zone at the site:
    Beskrivning

    Time Zone at the site:

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2825194 (Time Zone)
    UMLS CUI [1,2]
    C2825164 (Study Site)
    Equipment needed by:
    Beskrivning

    Equipment needed by:

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0014672 (Equipment)
    SNOMED
    246137000
    LOINC
    LP264340-3
    UMLS CUI [1,2]
    C0686904 (Patient need for (contextual qualifier))
    SNOMED
    103325001
    Tillbaka till toppen

    Similar models

    Ambulatory Blood Pressuure Monitoring Diary; Equipment Request

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    When dispensed?
    C1880359 (UMLS CUI-1)
    Dispensed at the End of which Week Visit?
    Item
    Dispensed at the End of which Week Visit?
    integer
    C1880359 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Doctor’s Name:
    Item
    Doctor’s Name:
    text
    C2361125 (UMLS CUI [1])
    Telephone Number:
    Item
    Telephone Number:
    integer
    C1515258 (UMLS CUI [1])
    Study Contact:
    Item
    Study Contact:
    text
    C0337611 (UMLS CUI [1])
    Item Group
    Ambulatory Blood Pressure Monitoring Diary
    C0430452 (UMLS CUI-1)
    Date and time of dose:
    Item
    Date and time of dose:
    datetime
    C1986447 (UMLS CUI [1])
    Date of Assessment:
    Item
    Date of Assessment:
    date
    C2985720 (UMLS CUI [1])
    Item Group
    Blood Pressure Measurement
    C0005823 (UMLS CUI-1)
    Item
    Time of Blood Pressure Measurement
    integer
    C0005823 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Time of Blood Pressure Measurement
    Code List
    Time of Blood Pressure Measurement
    CL Item
    Pre-dose (1)
    CL Item
    1 Hour Post-dose (2)
    CL Item
    2 Hours Post-dose (3)
    CL Item
    3 Hours Post-dose (4)
    CL Item
    4 Hours Post-dose (5)
    CL Item
    5 Hours Post-dose (6)
    CL Item
    6 Hours Post-dose (7)
    CL Item
    7 Hours Post-dose (8)
    CL Item
    8 Hours Post-dose (9)
    CL Item
    9 Hours Post-dose (10)
    CL Item
    10 Hours Post-dose (11)
    Item
    Activity at time of Blood Pressure Measurement
    integer
    C0005824 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0026606 (UMLS CUI [1,3])
    Activity at time of Blood Pressure Measurement
    Code List
    Activity at time of Blood Pressure Measurement
    CL Item
    Sedentary (or not very active) (1)
    CL Item
    (For example, napping, reading, watching TV, listening to music, etc.) (2)
    CL Item
    Low (activity) (2)
    CL Item
    (For example, using computer, cooking, eating, etc.) (4)
    CL Item
    Moderate (activity) (3)
    CL Item
    (For example, shopping at the mall, walking at a comfortable pace, etc.) (6)
    CL Item
    High (activity) (4)
    CL Item
    (For example, running, cycling, etc.) (8)
    CL Item
    Device not worn (5)
    Item Group
    Equipment Request
    C0014672 (UMLS CUI-1)
    C1272683 (UMLS CUI-2)
    Date of Request:
    Item
    Date of Request:
    date
    C1272683 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator’s name:
    Item
    Investigator’s name:
    text
    C2826892 (UMLS CUI [1])
    Site Number:
    Item
    Site Number:
    integer
    C2825164 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Requestor’s name:
    Item
    Requestor’s name:
    text
    C1272683 (UMLS CUI [1,1])
    C0027365 (UMLS CUI [1,2])
    Requestor’s phone number:
    Item
    Requestor’s phone number:
    integer
    C1272683 (UMLS CUI [1,1])
    C1515258 (UMLS CUI [1,2])
    Number of ABP 90207 monitors:
    Item
    Number of ABP 90207 monitors:
    integer
    C0237753 (UMLS CUI [1,1])
    C0181904 (UMLS CUI [1,2])
    Item
    Cuff Size(s):
    integer
    C0489480 (UMLS CUI [1])
    Cuff Size(s):
    Code List
    Cuff Size(s):
    CL Item
    Small (17 - 24 cm) (1)
    CL Item
    Medium (24 - 32cm) (2)
    CL Item
    Large (32 - 42 cm) (3)
    CL Item
    Extra Large (38 - 50 cm) (4)
    Time Zone at the site:
    Item
    Time Zone at the site:
    text
    C2825194 (UMLS CUI [1,1])
    C2825164 (UMLS CUI [1,2])
    Equipment needed by:
    Item
    Equipment needed by:
    date
    C0014672 (UMLS CUI [1,1])
    C0686904 (UMLS CUI [1,2])
    Tillbaka till toppen 

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