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ID

24413

Beschrijving

Part 9 of Module 17 - GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Week 8 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A 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

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Versies (1)
  1. 30/07/2017 30/07/2017 -
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glaxoSmithKline

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30 de julho de 2017

DOI

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Creative Commons BY-NC 3.0
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    GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Week 8

    Engels

    GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Week 8

    1 Formulieren  
    Orthostatic vital signs - instructions
    Beschrijving

    Orthostatic vital signs - instructions

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C1442085
    Orthostatic vital signs - instructions
    Beschrijving

    ONLY TAKE ORTHOSTATIC VITAL SIGNS IF A DOSE INCREASE OCCURS Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 minutes and erect measurements will be taken after the patient has been standing for a period of 1 minute. • The blood pressure cuff must be placed on the same arm throughout the study. • Ideally, the same study nurse/medical professional should conduct all the blood pressure/pulse measurements for each clinic visit and each patient throughout the study. • Pre-dose orthostatic measurements will commence approximately 30 minutes prior to dosing and each set will be separated by 10 minutes rest in the semi-supine position. • Two sets of stable, consecutive pre-dose semi-supine and erect blood pressure measurements as well as two sets of pulse rate measurements will be taken. Stable is defined as three measurements within +15mmHg of the lowest measurement. • One set of orthostatic blood pressure and pulse measurements will be taken 2 hours post dose.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1442085
    Pre-Dose Reading
    Beschrijving

    Pre-Dose Reading

    Alias
    UMLS CUI-1
    C1522609
    UMLS CUI-2
    C0439565
    Pre-dose reading
    Beschrijving

    Pre-dose reading

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1522609
    UMLS CUI [1,2]
    C0439565
    Time vitals taken
    Beschrijving

    Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Semi-supine systolic blood pressure
    Beschrijving

    Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Semi-supine diastolic blood pressure
    Beschrijving

    Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Beschrijving

    Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Time vitals taken
    Beschrijving

    Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Erect systolic blood pressure
    Beschrijving

    Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Erect diastolic blood pressure
    Beschrijving

    Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Beschrijving

    Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Time of dose
    Beschrijving

    Time of dose

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0040223
    Time of dose
    Beschrijving

    Time of dose

    Datatype

    time

    Maateenheden
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0040223
    Hr : Min
    Dose level
    Beschrijving

    Dose level

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0178602
    2 hours Post-Dose Reading 1
    Beschrijving

    2 hours Post-Dose Reading 1

    Alias
    UMLS CUI-1
    C1522609
    UMLS CUI-2
    C0439572
    Time vitals taken
    Beschrijving

    Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Semi-supine systolic blood pressure
    Beschrijving

    Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Semi-supine diastolic blood pressure
    Beschrijving

    Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Pulse
    Beschrijving

    Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Time vitals taken
    Beschrijving

    Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

    Datatype

    time

    Erect systolic blood pressure
    Beschrijving

    Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose. in mmHg; systolic/diastolic

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Erect diastolic blood-pressure
    Beschrijving

    Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Beschrijving

    Pre-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
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    Similar models

    GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Week 8

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Orthostatic vital signs - instructions
    C0518766 (UMLS CUI-1)
    C1442085 (UMLS CUI-2)
    Orthostatic vital signs - instructions
    Item
    Orthostatic vital signs - instructions
    text
    C0518766 (UMLS CUI [1,1])
    C1442085 (UMLS CUI [1,2])
    Item Group
    Pre-Dose Reading
    C1522609 (UMLS CUI-1)
    C0439565 (UMLS CUI-2)
    Pre-dose reading
    Item
    Pre-dose reading
    integer
    C1522609 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    Time vitals taken
    Item
    Time vitals taken
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Semi-supine Systolic blood pressure
    Item
    Semi-supine systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Semi-supine diastolic blood pressure
    Item
    Semi-supine diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Time vitals taken
    Item
    Time vitals taken
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Erect systolic blood pressure
    Item
    Erect systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Erect diastolic blood pressure
    Item
    Erect diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    Pulse Rate
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Item Group
    Time of dose
    C0013227 (UMLS CUI-1)
    C0040223 (UMLS CUI-2)
    Time of dose
    Item
    Time of dose
    time
    C0013227 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Dose level
    Item
    Dose level
    text
    C0178602 (UMLS CUI [1])
    Item Group
    2 hours Post-Dose Reading 1
    C1522609 (UMLS CUI-1)
    C0439572 (UMLS CUI-2)
    Time vitals taken
    Item
    Time vitals taken
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Semi-supine systolic blood pressure
    Item
    Semi-supine systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Semi-supine diastolic blood pressure
    Item
    Semi-supine diastolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Pulse Rate
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Time vitals taken
    Item
    Time vitals taken
    time
    Erect systolic blood pressure
    Item
    Erect systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Erect diastolic blood-pressure
    Item
    Erect diastolic blood-pressure
    integer
    C0428883 (UMLS CUI [1])
    Pulse Rate
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
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