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ID

39410

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2020-01-08 2020-01-08 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

8 januari 2020

DOI

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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

    Engelsk

    Study Conclusion

    1 Formulär  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative
    Beskrivning

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Study Name
    Beskrivning

    Study Name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348560 (Study Name)
    Subject ID
    Beskrivning

    Subject ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Site
    Beskrivning

    Study Site

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2825164 (Study Site)
    Study Conclusion
    Beskrivning

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    UMLS CUI-2
    C0008972 (Clinical Research)
    Date of subject completion or withdrawal
    Beskrivning

    Date of subject completion or withdrawal

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2983670 (Study End Date)
    Was the subject withdrawn from the study?
    Beskrivning

    Was the subject withdrawn from the study?

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    Primary reason for withdrawal
    Beskrivning

    Primary reason for withdrawal

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Was follow-up contact attempted three times?
    Beskrivning

    Was follow-up contact attempted three times?

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1522577 (follow-up)
    UMLS CUI [1,2]
    C0332158 (Contact with)
    SNOMED
    11723008
    Was a follow-up letter mailed?
    Beskrivning

    Was a follow-up letter mailed?

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1522577 (follow-up)
    UMLS CUI [1,2]
    C1096774 (Letter [Publication Type])
    LOINC
    LP74130-3
    UMLS CUI [1,3]
    C0013849 (Email)
    Specify follow-up letter
    Beskrivning

    Specify follow-up letter

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1522577 (follow-up)
    UMLS CUI [1,2]
    C1096774 (Letter [Publication Type])
    LOINC
    LP74130-3
    UMLS CUI [1,3]
    C2348235 (Specification)
    Status of Treatment Blind
    Beskrivning

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C0749659 (Treatment Status)
    UMLS CUI-2
    C2347038 (Blinded Clinical Study)
    Was the treatment blind broken during the study?
    Beskrivning

    Was the treatment blind broken during the study?

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3897431 (Subject Unblinding Event Record)
    Date/time blind broken
    Beskrivning

    Date/time blind broken

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C1264639 (Date/Time)
    SNOMED
    118575009
    Reason blind broken
    Beskrivning

    Reason blind broken

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Other reason blind broken
    Beskrivning

    Other reason blind broken

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,3]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
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    Similar models

    Study Conclusion

    1 Formulär
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    Tillbaka till toppen 

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