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ID

44255

Description

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline 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

Mots-clés

Versions (2)
  1. 19-02-19 19-02-19 -
  2. 20-09-21 20-09-21 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

20 september 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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    Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

    Anglais

    Ambulatory Blood Pressuure Monitoring Diary; Equipment Request

    1 Formulaires  
    When dispensed?
    Description

    When dispensed?

    Alias
    UMLS CUI-1
    C1880359
    Dispensed at the End of which Week Visit?
    Description

    Dispensed at the End of which Week Visit?

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1880359
    UMLS CUI [1,2]
    C0545082
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Doctor’s Name:
    Description

    Doctor’s Name:

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2361125
    Telephone Number:
    Description

    Telephone Number:

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1515258
    Study Contact:
    Description

    Study Contact:

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0337611
    Ambulatory Blood Pressure Monitoring Diary
    Description

    Ambulatory Blood Pressure Monitoring Diary

    Alias
    UMLS CUI-1
    C0430452
    Date and time of dose:
    Description

    Date and time of dose:

    Type de données

    datetime

    Alias
    UMLS CUI [1]
    C1986447
    Date of Assessment:
    Description

    Date of Assessment:

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2985720
    Blood Pressure Measurement
    Description

    Blood Pressure Measurement

    Alias
    UMLS CUI-1
    C0005823
    Time of Blood Pressure Measurement
    Description

    Time of Blood Pressure Measurement

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0005823
    UMLS CUI [1,2]
    C0040223
    Activity at time of Blood Pressure Measurement
    Description

    Check one activity level for each time point

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0005824
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0026606
    Equipment Request
    Description

    Equipment Request

    Alias
    UMLS CUI-1
    C0014672
    UMLS CUI-2
    C1272683
    Date of Request:
    Description

    Date of Request:

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C0011008
    Investigator’s name:
    Description

    Investigator’s name:

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2826892
    Site Number:
    Description

    Site Number:

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2825164
    UMLS CUI [1,2]
    C0237753
    Requestor’s name:
    Description

    Requestor’s name:

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C0027365
    Requestor’s phone number:
    Description

    Requestor’s phone number:

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1515258
    Number of ABP 90207 monitors:
    Description

    Number of ABP 90207 monitors:

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0181904
    Cuff Size(s):
    Description

    Cuff Size(s):

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0489480
    Time Zone at the site:
    Description

    Time Zone at the site:

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2825194
    UMLS CUI [1,2]
    C2825164
    Equipment needed by:
    Description

    Equipment needed by:

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0014672
    UMLS CUI [1,2]
    C0686904
    Retour au début de la page

    Similar models

    Ambulatory Blood Pressuure Monitoring Diary; Equipment Request

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    When dispensed?
    C1880359 (UMLS CUI-1)
    Dispensed at the End of which Week Visit?
    Item
    Dispensed at the End of which Week Visit?
    integer
    C1880359 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Doctor’s Name:
    Item
    Doctor’s Name:
    text
    C2361125 (UMLS CUI [1])
    Telephone Number:
    Item
    Telephone Number:
    integer
    C1515258 (UMLS CUI [1])
    Study Contact:
    Item
    Study Contact:
    text
    C0337611 (UMLS CUI [1])
    Item Group
    Ambulatory Blood Pressure Monitoring Diary
    C0430452 (UMLS CUI-1)
    Date and time of dose:
    Item
    Date and time of dose:
    datetime
    C1986447 (UMLS CUI [1])
    Date of Assessment:
    Item
    Date of Assessment:
    date
    C2985720 (UMLS CUI [1])
    Item Group
    Blood Pressure Measurement
    C0005823 (UMLS CUI-1)
    Item
    Time of Blood Pressure Measurement
    integer
    C0005823 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Time of Blood Pressure Measurement
    Code List
    Time of Blood Pressure Measurement
    CL Item
    Pre-dose (1)
    CL Item
    1 Hour Post-dose (2)
    CL Item
    2 Hours Post-dose (3)
    CL Item
    3 Hours Post-dose (4)
    CL Item
    4 Hours Post-dose (5)
    CL Item
    5 Hours Post-dose (6)
    CL Item
    6 Hours Post-dose (7)
    CL Item
    7 Hours Post-dose (8)
    CL Item
    8 Hours Post-dose (9)
    CL Item
    9 Hours Post-dose (10)
    CL Item
    10 Hours Post-dose (11)
    Item
    Activity at time of Blood Pressure Measurement
    integer
    C0005824 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0026606 (UMLS CUI [1,3])
    Activity at time of Blood Pressure Measurement
    Code List
    Activity at time of Blood Pressure Measurement
    CL Item
    Sedentary (or not very active) (1)
    CL Item
    (For example, napping, reading, watching TV, listening to music, etc.) (2)
    CL Item
    Low (activity) (2)
    CL Item
    (For example, using computer, cooking, eating, etc.) (4)
    CL Item
    Moderate (activity) (3)
    CL Item
    (For example, shopping at the mall, walking at a comfortable pace, etc.) (6)
    CL Item
    High (activity) (4)
    CL Item
    (For example, running, cycling, etc.) (8)
    CL Item
    Device not worn (5)
    Item Group
    Equipment Request
    C0014672 (UMLS CUI-1)
    C1272683 (UMLS CUI-2)
    Date of Request:
    Item
    Date of Request:
    date
    C1272683 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator’s name:
    Item
    Investigator’s name:
    text
    C2826892 (UMLS CUI [1])
    Site Number:
    Item
    Site Number:
    integer
    C2825164 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Requestor’s name:
    Item
    Requestor’s name:
    text
    C1272683 (UMLS CUI [1,1])
    C0027365 (UMLS CUI [1,2])
    Requestor’s phone number:
    Item
    Requestor’s phone number:
    integer
    C1272683 (UMLS CUI [1,1])
    C1515258 (UMLS CUI [1,2])
    Number of ABP 90207 monitors:
    Item
    Number of ABP 90207 monitors:
    integer
    C0237753 (UMLS CUI [1,1])
    C0181904 (UMLS CUI [1,2])
    Item
    Cuff Size(s):
    integer
    C0489480 (UMLS CUI [1])
    Cuff Size(s):
    Code List
    Cuff Size(s):
    CL Item
    Small (17 - 24 cm) (1)
    CL Item
    Medium (24 - 32cm) (2)
    CL Item
    Large (32 - 42 cm) (3)
    CL Item
    Extra Large (38 - 50 cm) (4)
    Time Zone at the site:
    Item
    Time Zone at the site:
    text
    C2825194 (UMLS CUI [1,1])
    C2825164 (UMLS CUI [1,2])
    Equipment needed by:
    Item
    Equipment needed by:
    date
    C0014672 (UMLS CUI [1,1])
    C0686904 (UMLS CUI [1,2])
    Retour au début de la page 

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