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27260

Description

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) 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: Parkinson Disease Module: Early Withdrawal

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Versions (1)
  1. 11/6/17 11/6/17 -
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GlaxoSmithKline

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November 6, 2017

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    GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188

    English

    Early Withdrawal

    1 forms  
    1. StudyEvent: ODM
      1. Early Withdrawal
    Vital signs
    Description

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0031809
    Sitting blood pressure systolic
    Description

    Sitting blood pressure systolic

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0277814
    mmHg
    Sitting blood pressure diastolic
    Description

    Sitting blood pressure diastolic

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0277814
    mmHg
    Sitting heart rate
    Description

    Sitting heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0277814
    beats/min
    Weight (without shoes)
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Healthcare resource utilisation - Visits/Contacts with Physicians
    Description

    Healthcare resource utilisation - Visits/Contacts with Physicians

    Alias
    UMLS CUI-1
    C1704738
    UMLS CUI-2
    C0031831
    UMLS CUI-3
    C0545082
    In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
    Description

    If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0583555
    Date of Visit
    Description

    date of visit physician

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C0031831
    Type of physician
    Description

    Type of physician

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0031831
    UMLS CUI [1,2]
    C0332307
    Visit location
    Description

    Visit location

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0450429
    Was the Visit RLS Related?
    Description

    A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0439849
    Were any tests or procedures prescribed or conducted at this visit?
    Description

    tests or procedures prescribed

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0430022
    UMLS CUI [2]
    C0033080
    Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
    Description

    Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners

    Alias
    UMLS CUI-1
    C1704738
    UMLS CUI-2
    C0030450
    UMLS CUI-3
    C0545082
    In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
    Description

    If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0030450
    Date of visit
    Description

    date of visit paramedical practitioner

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0030450
    UMLS CUI [1,2]
    C1320303
    Type of paramedical practitioner
    Description

    Type of paramedical practitioner

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030450
    UMLS CUI [1,2]
    C0332307
    Visit location
    Description

    Visit location

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0450429
    Was the visit RLS related?
    Description

    A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0439849
    Healthcare resource utilisation - Hospitalisation
    Description

    Healthcare resource utilisation - Hospitalisation

    Alias
    UMLS CUI-1
    C1704738
    UMLS CUI-2
    C0019993
    In the past 4 weeks...was the patient hospitalised?
    Description

    If ’No’, please leave the rest of this page blank If ’Yes’, please describe each hospitalisation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019993
    Date of admission
    Description

    date of admission

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302393
    Date of discharge
    Description

    date of discharge

    Data type

    date

    Alias
    UMLS CUI [1]
    C2361123
    Main reason for stay
    Description

    Hospitalisation cause

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0019993
    UMLS CUI [1,2]
    C0392360
    Was the Visit RLS Related?
    Description

    A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0439849
    Type of ward
    Description

    type of ward

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1305702
    UMLS CUI [1,2]
    C0332307
    Length of stay on ward
    Description

    in days

    Data type

    integer

    Measurement units
    • days
    Alias
    UMLS CUI [1,1]
    C1305702
    UMLS CUI [1,2]
    C0023303
    days
    Healthcare resource utilisation - accident & emergency / emergency room visits
    Description

    Healthcare resource utilisation - accident & emergency / emergency room visits

    Alias
    UMLS CUI-1
    C1704738
    UMLS CUI-2
    C0562508
    UMLS CUI-3
    C0545082
    In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
    Description

    If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0562508
    UMLS CUI [1,2]
    C0545082
    Date of visit
    Description

    Date of visit in A&E

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0562508
    UMLS CUI [1,2]
    C1320303
    Was the visit RLS related?
    Description

    A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0439849
    Laboratory Evaluation
    Description

    Laboratory Evaluation

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0430370
    Date of blood sample
    Description

    Date of blood sample

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Were any clinically significant abnormalities detected?
    Description

    If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this book and repeat at Follow-up.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1853129
    What was the result of the urine dipstick performed at this visit?
    Description

    Please perform a urine dipstick test for presence of blood or protein. If ’Positive’, please record details in the Adverse Experiences and/or SAE Section at the back of this book, send a sample to Quest Diagnostics for further evaluation and repeat at Follow-up.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0430370
    UMLS CUI [1,2]
    C0456984
    Back to the top of the page

    Similar models

    Early Withdrawal

    1 forms
    1. StudyEvent: ODM
      1. Early Withdrawal
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Sitting blood pressure systolic
    Item
    Sitting blood pressure systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Sitting blood pressure diastolic
    Item
    Sitting blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Sitting heart rate
    Item
    Sitting heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Weight
    Item
    Weight (without shoes)
    float
    C0005910 (UMLS CUI [1])
    Item Group
    Healthcare resource utilisation - Visits/Contacts with Physicians
    C1704738 (UMLS CUI-1)
    C0031831 (UMLS CUI-2)
    C0545082 (UMLS CUI-3)
    Visits with physicians
    Item
    In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
    boolean
    C0583555 (UMLS CUI [1])
    date of visit physician
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
    Item
    Type of physician
    integer
    C0031831 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Type of physician
    Code List
    Type of physician
    CL Item
    Cardiologist (1)
    CL Item
    Diabetologist (2)
    CL Item
    Dermatologist (3)
    CL Item
    Endocrinologist (4)
    CL Item
    ENT (Ear Nose & Throat) (5)
    CL Item
    Gastroenterologist (6)
    CL Item
    General/Internal Medical (7)
    CL Item
    General Practitioner/Family Practitioner  (8)
    CL Item
    Geriatrician (9)
    CL Item
    Gynaecologist (10)
    CL Item
    Infectious Disease (11)
    CL Item
    Nephrologist (12)
    CL Item
    Neurologist (13)
    CL Item
    Psychiatrist (14)
    CL Item
    Orthopaedic (15)
    CL Item
    Oncologist (16)
    CL Item
    Ophthalmologist (17)
    CL Item
    Respiratory/Chest Physician  (18)
    CL Item
    Rheumatologist (19)
    CL Item
    Urologist (20)
    CL Item
    Sleep Disorder Specialist  (21)
    CL Item
    Other (99)
    Item
    Visit location
    integer
    C0545082 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    Visit location
    Code List
    Visit location
    CL Item
    Non hospital Office visit (eg GP surgery, Specialist's office etc) (1)
    CL Item
    Hospital Out Patient visit (2)
    CL Item
    At the Patient's home / domiciliary visit (3)
    Item
    Was the Visit RLS Related?
    text
    C0035258 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    Related to RLS
    Code List
    Was the Visit RLS Related?
    CL Item
    directly (1)
    CL Item
    indirectly (2)
    CL Item
    not related (3)
    Item
    Were any tests or procedures prescribed or conducted at this visit?
    integer
    C0430022 (UMLS CUI [1])
    C0033080 (UMLS CUI [2])
    tests or procedures during visit
    Code List
    Were any tests or procedures prescribed or conducted at this visit?
    CL Item
    yes (1)
    CL Item
    no (2)
    CL Item
    unknown (3)
    Item Group
    Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
    C1704738 (UMLS CUI-1)
    C0030450 (UMLS CUI-2)
    C0545082 (UMLS CUI-3)
    patient visit with paramedical practitioners
    Item
    In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
    boolean
    C0545082 (UMLS CUI [1,1])
    C0030450 (UMLS CUI [1,2])
    date of visit paramedical practitioner
    Item
    Date of visit
    date
    C0030450 (UMLS CUI [1,1])
    C1320303 (UMLS CUI [1,2])
    Item
    Type of paramedical practitioner
    integer
    C0030450 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Type of paramedical practitioner
    Code List
    Type of paramedical practitioner
    CL Item
    Acupuncturist (1)
    CL Item
    Chiropodist/ Footcare Practitioner (2)
    CL Item
    Chiropractor (3)
    CL Item
    Dentist (4)
    CL Item
    Dietician (5)
    CL Item
    Homeopath/Herbalist (6)
    CL Item
    Nurse (7)
    CL Item
    Osteopath (8)
    CL Item
    Physiotherapist (9)
    CL Item
    Other (99)
    Item
    Visit location
    integer
    C0545082 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    Visit location
    Code List
    Visit location
    CL Item
    Non hospital Office visit (eg GP surgery, Specialist's office etc) (1)
    CL Item
    Hospital Out Patient visit (2)
    CL Item
    At the Patient's home / domiciliary visit (3)
    Item
    Was the visit RLS related?
    text
    C0035258 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    Related to RLS
    Code List
    Was the visit RLS related?
    CL Item
    directly (1)
    CL Item
    indirectly (2)
    CL Item
    not related (3)
    Item Group
    Healthcare resource utilisation - Hospitalisation
    C1704738 (UMLS CUI-1)
    C0019993 (UMLS CUI-2)
    Hospitalisation
    Item
    In the past 4 weeks...was the patient hospitalised?
    boolean
    C0019993 (UMLS CUI [1])
    date of admission
    Item
    Date of admission
    date
    C1302393 (UMLS CUI [1])
    date of discharge
    Item
    Date of discharge
    date
    C2361123 (UMLS CUI [1])
    Hospitalisation cause
    Item
    Main reason for stay
    text
    C0019993 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Item
    Was the Visit RLS Related?
    text
    C0035258 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    Related to RLS
    Code List
    Was the Visit RLS Related?
    CL Item
    directly (1)
    CL Item
    indirectly (2)
    CL Item
    not related (3)
    Item
    Type of ward
    integer
    C1305702 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    type of ward
    Code List
    Type of ward
    CL Item
    Cardiovascular (1)
    CL Item
    Dermatological (2)
    CL Item
    Endocrinological (3)
    CL Item
    ENT (Ear, Nose & Throat)  (4)
    CL Item
    Gastroenterological (5)
    CL Item
    General Medical (6)
    CL Item
    Geriatric (7)
    CL Item
    Gynaecological (8)
    CL Item
    Infectious Disease  (9)
    CL Item
    Nephrological (10)
    CL Item
    Intensive Care  (11)
    CL Item
    Neurological  (12)
    CL Item
    Psychiatric (13)
    CL Item
    Orthopaedic  (14)
    CL Item
    Oncology (15)
    CL Item
    Ophthalmological  (16)
    CL Item
    Respiratory/Chest  (17)
    CL Item
    Rheumatological  (18)
    CL Item
    Urological (19)
    CL Item
    Other (99)
    length of stay on ward
    Item
    Length of stay on ward
    integer
    C1305702 (UMLS CUI [1,1])
    C0023303 (UMLS CUI [1,2])
    Item Group
    Healthcare resource utilisation - accident & emergency / emergency room visits
    C1704738 (UMLS CUI-1)
    C0562508 (UMLS CUI-2)
    C0545082 (UMLS CUI-3)
    A&E visits
    Item
    In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
    boolean
    C0562508 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    Date of visit in A&E
    Item
    Date of visit
    date
    C0562508 (UMLS CUI [1,1])
    C1320303 (UMLS CUI [1,2])
    Item
    Was the visit RLS related?
    text
    C0035258 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    Related to RLS
    Code List
    Was the visit RLS related?
    CL Item
    directly (1)
    CL Item
    indirectly (2)
    CL Item
    not related (3)
    Item Group
    Laboratory Evaluation
    C0022885 (UMLS CUI-1)
    C0430370 (UMLS CUI-2)
    Date of blood sample
    Item
    Date of blood sample
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    abnormalities laboratory
    Item
    Were any clinically significant abnormalities detected?
    boolean
    C1853129 (UMLS CUI [1])
    Item
    What was the result of the urine dipstick performed at this visit?
    integer
    C0430370 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    urine dipstick result
    Code List
    What was the result of the urine dipstick performed at this visit?
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    Back to the top of the page 

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