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25336

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Study ID: 101468/191 Clinical Study ID: SKF-101468/191 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Ropinirole in Subjects with Restless Legs Syndrome (RLS) Suffering from Periodic Leg Movements of Sleep (PLMS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome

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Versioner (2)
  1. 2017-09-01 2017-09-01 -
  2. 2017-09-01 2017-09-01 -
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1 september 2017

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    GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 12 Day (Form 16)

    Engelsk

    GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 12 Day (Form 16)

    1 Formulär  
    General Information
    Beskrivning

    General Information

    Center Number
    Beskrivning

    Center Number

    Datatyp

    integer

    Patient Number
    Beskrivning

    Patient Number

    Datatyp

    integer

    Patient Initials
    Beskrivning

    Patient Initials

    Datatyp

    text

    Visit Date
    Beskrivning

    Visit Date

    Datatyp

    date

    Investigational Product Record since last visit
    Beskrivning

    Investigational Product Record since last visit

    Please complete the investigational product record in the Investigational Product and Compliance Section at the back of this book. Please complete the Investigational Product Interruption record in the Investigational Product and Compliance Section at the back of this book.
    Beskrivning

    Investigational Product Record since last visit

    Datatyp

    boolean

    RSL Rating Scale
    Beskrivning

    RSL Rating Scale

    INVESTIGATOR: Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
    Beskrivning

    RSL Rating Scale

    Datatyp

    boolean

    Vital Signs
    Beskrivning

    Vital Signs

    Weight (without shoes)
    Beskrivning

    Weight

    Datatyp

    float

    Måttenheter
    • kg/lbs
    kg/lbs
    Pulse (after 5 minutes sitting)
    Beskrivning

    Pulse

    Datatyp

    integer

    Måttenheter
    • beats/min
    beats/min
    Sitting Blood Pressure (after 5 minutes sitting) systolic
    Beskrivning

    Sitting Blood Pressure systolic

    Datatyp

    integer

    Måttenheter
    • mmHg
    mmHg
    Sitting Blood pressure (after 5 minutes sitting) diastolic
    Beskrivning

    Sitting Blood pressure diastolic

    Datatyp

    integer

    Måttenheter
    • mmHg
    mmHg
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    Beskrivning

    Medical Procedures

    Datatyp

    boolean

    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    Beskrivning

    Concomitant Medication

    Datatyp

    boolean

    Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the Week 8 Visit?" in the Adverse Experience section at the back of this book.
    Beskrivning

    Adverse Experiences

    Datatyp

    boolean

    Laboratory Evaluation
    Beskrivning

    Laboratory Evaluation

    Date of blood sample
    Beskrivning

    Date of blood sample

    Datatyp

    date

    Were any clinically significant abnormalities detected?
    Beskrivning

    Results

    Datatyp

    text

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    Similar models

    GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 12 Day (Form 16)

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    General Information
    Center Number
    Item
    Center Number
    integer
    Patient Number
    Item
    Patient Number
    integer
    Patient Initials
    Item
    Patient Initials
    text
    Visit Date
    Item
    Visit Date
    date
    Item Group
    Investigational Product Record since last visit
    Investigational Product Record since last visit
    Item
    Please complete the investigational product record in the Investigational Product and Compliance Section at the back of this book. Please complete the Investigational Product Interruption record in the Investigational Product and Compliance Section at the back of this book.
    boolean
    Item Group
    RSL Rating Scale
    RSL Rating Scale
    Item
    INVESTIGATOR: Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
    boolean
    Item Group
    Vital Signs
    Weight
    Item
    Weight (without shoes)
    float
    Pulse
    Item
    Pulse (after 5 minutes sitting)
    integer
    Sitting Blood Pressure systolic
    Item
    Sitting Blood Pressure (after 5 minutes sitting) systolic
    integer
    Sitting Blood pressure diastolic
    Item
    Sitting Blood pressure (after 5 minutes sitting) diastolic
    integer
    Medical Procedures
    Item
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    boolean
    Concomitant Medication
    Item
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    boolean
    Adverse Experiences
    Item
    Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the Week 8 Visit?" in the Adverse Experience section at the back of this book.
    boolean
    Item Group
    Laboratory Evaluation
    Date of blood sample
    Item
    Date of blood sample
    date
    Item
    Were any clinically significant abnormalities detected?
    text
    Results
    Code List
    Were any clinically significant abnormalities detected?
    CL Item
    No (1)
    CL Item
    Yes -> If "Positive", please record details in the Pregnancy Information section on the Study Conclusion page at the back of this book. (2)
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