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ID

25667

Description

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Study conclusion.

Keywords

Versions (2)
  1. 8/25/17 8/25/17 -
  2. 9/8/17 9/8/17 -
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September 8, 2017

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Creative Commons BY-NC 3.0
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    Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

    English

    Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

    1 forms  
    General information
    Description

    General information

    Protocol identifier
    Description

    Protocol identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826693 (Study Identifier)
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit Description
    Description

    Visit Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0678257 (Description)
    LOINC
    LP6800-9
    Pregnancy information
    Description

    Pregnancy information

    Did the subject become pregnant during the study?
    Description

    If Yes, complete Pregnancy Notification form.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    Study conclusion
    Description

    Study conclusion

    Date of subject completion or withdrawal
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Was the subject withdrawn from the study?
    Description

    Withdrawal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C1519255 (Serious Adverse Event)
    If Yes, check the primary reason for withdrawal:
    Description

    reason withdrawal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    If other reason, specify
    Description

    other reason withdrawal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,3]
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    Investigator comment log
    Description

    Investigator comment log

    CRF page number if applicable
    Description

    CRF page number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    UMLS CUI [1,2]
    C1516308 (Case Report Form)
    UMLS CUI [1,3]
    C1515022 (Submission)
    LOINC
    LP91032-0
    Comment
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Investigator's signature
    Description

    Investigator's signature

    Investigator’s Signature
    Description

    Investigator Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Date
    Description

    signature date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0807937 (Signature date)
    LOINC
    MTHU008294
    Investigator’s name (print)
    Description

    Investigator name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
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    Similar models

    Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    General information
    Protocol identifier
    Item
    Protocol identifier
    integer
    C2826693 (UMLS CUI [1])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Visit Description
    Item
    Visit Description
    text
    C0545082 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Item Group
    Pregnancy information
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1])
    Did the subject become pregnant during the study?
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (Y)
    C0549206 (UMLS CUI-1)
    (Comment:en)
    CL Item
    No (N)
    C0232973 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Not Applicable (not of childbearing potential or male) (x)
    C1272460 (UMLS CUI-1)
    (Comment:en)
    Item Group
    Study conclusion
    Date
    Item
    Date of subject completion or withdrawal
    date
    C0011008 (UMLS CUI [1])
    Withdrawal
    Item
    Was the subject withdrawn from the study?
    boolean
    C2349954 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    If Yes, check the primary reason for withdrawal:
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    reason withdrawal
    Code List
    If Yes, check the primary reason for withdrawal:
    CL Item
    Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate) (1)
    C0877248 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Lost to follow-up (2)
    C1302313 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Protocol violation (3)
    C1709750 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Subject decided to withdraw from the study (4)
    C2348571 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Lack of efficacy (5)
    C0235828 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Sponsor terminated study (6)
    C1710224 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Dyskinesia (28)
    C0013384 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other (Z)
    C0205394 (UMLS CUI-1)
    (Comment:en)
    other reason withdrawal
    Item
    If other reason, specify
    text
    C2349954 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C3840932 (UMLS CUI [1,3])
    Item Group
    Investigator comment log
    CRF page number
    Item
    CRF page number if applicable
    integer
    C0237753 (UMLS CUI [1,1])
    C1516308 (UMLS CUI [1,2])
    C1515022 (UMLS CUI [1,3])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Investigator's signature
    Investigator Signature
    Item
    Investigator’s Signature
    text
    C2346576 (UMLS CUI [1])
    signature date
    Item
    Date
    date
    C0807937 (UMLS CUI [1])
    Investigator name
    Item
    Investigator’s name (print)
    text
    C2826892 (UMLS CUI [1])
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