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39410

Descrizione

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

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versioni (1)
  1. 08/01/20 08/01/20 -
Titolare del copyright

GlaxoSmithKline

Caricato su

8 gennaio 2020

DOI

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Licenza

Creative Commons BY-NC 3.0
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    Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease

    Inglese

    Study Conclusion

    1 moduli  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative
    Descrizione

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Study Name
    Descrizione

    Study Name

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348560
    Subject ID
    Descrizione

    Subject ID

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348585
    Study Site
    Descrizione

    Study Site

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2825164
    Study Conclusion
    Descrizione

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Date of subject completion or withdrawal
    Descrizione

    Date of subject completion or withdrawal

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C2983670
    Was the subject withdrawn from the study?
    Descrizione

    Was the subject withdrawn from the study?

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Primary reason for withdrawal
    Descrizione

    Primary reason for withdrawal

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
    Was follow-up contact attempted three times?
    Descrizione

    Was follow-up contact attempted three times?

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1522577
    UMLS CUI [1,2]
    C0332158
    Was a follow-up letter mailed?
    Descrizione

    Was a follow-up letter mailed?

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1522577
    UMLS CUI [1,2]
    C1096774
    UMLS CUI [1,3]
    C0013849
    Specify follow-up letter
    Descrizione

    Specify follow-up letter

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1522577
    UMLS CUI [1,2]
    C1096774
    UMLS CUI [1,3]
    C2348235
    Status of Treatment Blind
    Descrizione

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C0749659
    UMLS CUI-2
    C2347038
    Was the treatment blind broken during the study?
    Descrizione

    Was the treatment blind broken during the study?

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3897431
    Date/time blind broken
    Descrizione

    Date/time blind broken

    Tipo di dati

    datetime

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C1264639
    Reason blind broken
    Descrizione

    Reason blind broken

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Other reason blind broken
    Descrizione

    Other reason blind broken

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0205394
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    Similar models

    Study Conclusion

    1 moduli
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Study Name
    Item
    Study Name
    text
    C2348560 (UMLS CUI [1])
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Study Site
    Item
    Study Site
    text
    C2825164 (UMLS CUI [1])
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Date of subject completion or withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    Was the subject withdrawn from the study?
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    Primary reason for withdrawal
    integer
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Primary reason for withdrawal
    Code List
    Primary reason for withdrawal
    CL Item
    Adverse Event (1)
    CL Item
    Lack of efficacy (2)
    CL Item
    Protocol deviation (3)
    CL Item
    Subject reached protocol defined (4)
    CL Item
    Study closed/terminated (5)
    CL Item
    Lost to follow-up (6)
    CL Item
    Investigator discretion (7)
    CL Item
    Withdrew consent (8)
    Was follow-up contact attempted three times?
    Item
    Was follow-up contact attempted three times?
    boolean
    C1522577 (UMLS CUI [1,1])
    C0332158 (UMLS CUI [1,2])
    Was a follow-up letter mailed?
    Item
    Was a follow-up letter mailed?
    boolean
    C1522577 (UMLS CUI [1,1])
    C1096774 (UMLS CUI [1,2])
    C0013849 (UMLS CUI [1,3])
    Specify follow-up letter
    Item
    Specify follow-up letter
    text
    C1522577 (UMLS CUI [1,1])
    C1096774 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Status of Treatment Blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    Was the treatment blind broken during the study?
    Item
    Was the treatment blind broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    Date/time blind broken
    Item
    Date/time blind broken
    datetime
    C3897431 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Item
    Reason blind broken
    integer
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason blind broken
    Code List
    Reason blind broken
    CL Item
    Medical emergency (1)
    CL Item
    Other (2)
    Other reason blind broken
    Item
    Other reason blind broken
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
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