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25338

Beschreibung

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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  1. 01.09.17 01.09.17 -
  2. 01.09.17 01.09.17 -
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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)

    Englisch

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

    1 Formulare  
    General Information
    Beschreibung

    General Information

    Center Number
    Beschreibung

    Center Number

    Datentyp

    integer

    Patient Number
    Beschreibung

    Patient Number

    Datentyp

    integer

    Patient Initials
    Beschreibung

    Patient Initials

    Datentyp

    text

    Visit Date
    Beschreibung

    Visit Date

    Datentyp

    date

    Investigational Product Record since last visit
    Beschreibung

    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.
    Beschreibung

    Investigational Product Record since last visit

    Datentyp

    boolean

    RSL Rating Scale
    Beschreibung

    RSL Rating Scale

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

    RSL Rating Scale

    Datentyp

    boolean

    Vital Signs
    Beschreibung

    Vital Signs

    Weight (without shoes)
    Beschreibung

    Weight

    Datentyp

    float

    Maßeinheiten
    • kg/lbs
    kg/lbs
    Pulse (after 5 minutes sitting)
    Beschreibung

    Pulse

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    beats/min
    Sitting Blood Pressure (after 5 minutes sitting) systolic
    Beschreibung

    Sitting Blood Pressure systolic

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    mmHg
    Sitting Blood pressure (after 5 minutes sitting) diastolic
    Beschreibung

    Sitting Blood pressure diastolic

    Datentyp

    integer

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

    Medical Procedures

    Datentyp

    boolean

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

    Concomitant Medication

    Datentyp

    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.
    Beschreibung

    Adverse Experiences

    Datentyp

    boolean

    Laboratory Evaluation
    Beschreibung

    Laboratory Evaluation

    Date of blood sample
    Beschreibung

    Date of blood sample

    Datentyp

    date

    Were any clinically significant abnormalities detected?
    Beschreibung

    Results

    Datentyp

    text

    Pregnancy Dipstick
    Beschreibung

    Pregnancy Dipstick

    Is the patient a female of childbearing potential?
    Beschreibung

    Pregnancy Dipstick

    Datentyp

    text

    Results pregnancy dipstick
    Beschreibung

    Results pregnancy dipstick

    Datentyp

    text

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    Ähnliche Modelle

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

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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)
    Item Group
    Pregnancy Dipstick
    Item
    Is the patient a female of childbearing potential?
    text
    Pregnancy Dipstick
    Code List
    Is the patient a female of childbearing potential?
    CL Item
    No (1)
    CL Item
    Yes -> If "Yes", please perform a pregnancy dipstick test and record results below. (2)
    Item
    Results pregnancy dipstick
    text
    Results pregnancy dipstick
    Code List
    Results pregnancy dipstick
    CL Item
    Negative (1)
    CL Item
    Positive -> If "Posititve", please record details in the Pregnancy Information section on the Study Conclusion page at the end of this book. (2)
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