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ID

43563

Description

Study part: Vital Signs. A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. 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. Study ID: 101468/206. Clinical Study ID: 101468/206.

Keywords

Versions (2)
  1. 9/9/17 9/9/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

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License

Creative Commons BY-NC 3.0
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    Vital Signs (VS) Ropinirole Restless Legs Syndrom NCT00355641

    English

    Vital Signs

    1 forms  
    1. StudyEvent: ODM
      1. Vital Signs
    VITAL SIGNS
    Description

    VITAL SIGNS

    Alias
    UMLS CUI-1
    C0518766
    Dosing date/time
    Description

    date and time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Height
    Description

    Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    PRE-DOSE
    Description

    PRE-DOSE

    Alias
    UMLS CUI-1
    C0439565
    2. Actual date/time
    Description

    date and time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    3. Blood pressure - Semi-supine
    Description

    Blood pressure supine

    Data type

    text

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0005823
    UMLS CUI [1,2]
    C0038846
    mmHg
    4. Heart rate - Semi-supine
    Description

    Heart rate supine

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    beats/min
    5. Blood pressure - Standing
    Description

    Blood pressure - Standing

    Data type

    text

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0580945
    mmHg
    6. Heart rate - Standing
    Description

    Heart rate - Standing

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C2029905
    beats/min
    2 HOURS POST-DOSE
    Description

    2 HOURS POST-DOSE

    Alias
    UMLS CUI-1
    C0439568
    7. Actual date/time
    Description

    date and time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    8. Blood pressure - Semi-supine
    Description

    Blood pressure supine

    Data type

    text

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0005823
    UMLS CUI [1,2]
    C0038846
    mmHg
    9. Heart rate - Semi-supine
    Description

    Heart rate supine

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    beats/min
    10. Blood pressure - Standing
    Description

    Blood pressure - Standing

    Data type

    text

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0580945
    mmHg
    11. Heart rate - Standing
    Description

    Heart rate - Standing

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C2029905
    beats/min
    4 HOURS POST-DOSE
    Description

    4 HOURS POST-DOSE

    Alias
    UMLS CUI-1
    C0439568
    12. Actual date/time
    Description

    date and time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    13. Blood pressure - Semi-supine
    Description

    Blood pressure supine

    Data type

    text

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0005823
    UMLS CUI [1,2]
    C0038846
    mmHg
    14. Heart rate - Semi-supine
    Description

    Heart rate supine

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    beats/min
    15. Blood pressure - Standing
    Description

    Blood pressure - Standing

    Data type

    text

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0580945
    mmHg
    16. Heart rate - Standing
    Description

    Heart rate - Standing

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C2029905
    beats/min
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    Similar models

    Vital Signs

    1 forms
    1. StudyEvent: ODM
      1. Vital Signs
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    VITAL SIGNS
    C0518766 (UMLS CUI-1)
    date and time
    Item
    Dosing date/time
    datetime
    C1264639 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Item Group
    PRE-DOSE
    C0439565 (UMLS CUI-1)
    date and time
    Item
    2. Actual date/time
    datetime
    C1264639 (UMLS CUI [1])
    Blood pressure supine
    Item
    3. Blood pressure - Semi-supine
    text
    C0005823 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart rate supine
    Item
    4. Heart rate - Semi-supine
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Blood pressure - Standing
    Item
    5. Blood pressure - Standing
    text
    C0580945 (UMLS CUI [1])
    Heart rate - Standing
    Item
    6. Heart rate - Standing
    integer
    C2029905 (UMLS CUI [1])
    Item Group
    2 HOURS POST-DOSE
    C0439568 (UMLS CUI-1)
    date and time
    Item
    7. Actual date/time
    datetime
    C1264639 (UMLS CUI [1])
    Blood pressure supine
    Item
    8. Blood pressure - Semi-supine
    text
    C0005823 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart rate supine
    Item
    9. Heart rate - Semi-supine
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Blood pressure - Standing
    Item
    10. Blood pressure - Standing
    text
    C0580945 (UMLS CUI [1])
    Heart rate - Standing
    Item
    11. Heart rate - Standing
    integer
    C2029905 (UMLS CUI [1])
    Item Group
    4 HOURS POST-DOSE
    C0439568 (UMLS CUI-1)
    date and time
    Item
    12. Actual date/time
    datetime
    C1264639 (UMLS CUI [1])
    Blood pressure supine
    Item
    13. Blood pressure - Semi-supine
    text
    C0005823 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart rate supine
    Item
    14. Heart rate - Semi-supine
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Blood pressure - Standing
    Item
    15. Blood pressure - Standing
    text
    C0580945 (UMLS CUI [1])
    Heart rate - Standing
    Item
    16. Heart rate - Standing
    integer
    C2029905 (UMLS CUI [1])
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