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ID

36028

Beskrivning

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Pregnancy Information and Study Conclusion form. It has to be filled in for follow-up.

Nyckelord

Versioner (1)
  1. 2019-04-09 2019-04-09 -
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GlaxoSmithKline

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9 april 2019

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Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Engelsk

    Pregnancy Information, Study Conclusion

    1 Formulär  
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject No.
    Beskrivning

    Subject No.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Panel ID
    Beskrivning

    Panel ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Visit Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Pregnancy Information
    Beskrivning

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI-2
    C1533716 (Information)
    Did the subject become pregnant during the study?
    Beskrivning

    (mark one box below) If 'Yes' record details on Pregnancy Notification Form.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3828490 (Pregnant During the Study)
    Did the female partner of a male patient become pregnant during the study?
    Beskrivning

    (mark one box below) If 'Yes' record details on Pregnancy Notification Form.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0919624 (Pregnancy of partner)
    UMLS CUI [1,2]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [1,3]
    C0008972 (Clinical Research)
    Study Conclusion
    Beskrivning

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    UMLS CUI-2
    C0008972 (Clinical Research)
    Did the subject complete the study as planned?
    Beskrivning

    Subject completed study

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2983670 (Study End Date)
    UMLS CUI [1,2]
    C2986196 (Planned Activity Planned Duration)
    If subject did not complete the study, please mark the one most appropriate category
    Beskrivning

    IF you tick AE, please complete AE form.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3827242 (Patient did not Complete Study)
    If other reason, please specify
    Beskrivning

    Other reason

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    UMLS CUI [1,2]
    C1521902 (To specify)
    Comments on reason for withdrawal
    Beskrivning

    Comments

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    Date of Withdrawal
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time of Withdrawal
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Date of Final Dose
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1762893 (Date last dose)
    LOINC
    LP29043-4
    Time of Final Dose
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0946444 (Time last dose)
    LOINC
    LP29120-0
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    Similar models

    Pregnancy Information, Study Conclusion

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did the subject become pregnant during the study?
    text
    C3828490 (UMLS CUI [1])
    Pregnant during study
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Not applicable (not of childbearing potential or male) (X)
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Did the female partner of a male patient become pregnant during the study?
    text
    C0919624 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008972 (UMLS CUI [1,3])
    undefined item
    Code List
    Did the female partner of a male patient become pregnant during the study?
    CL Item
    Not applicable (subject is female, female partner not of childbearing potential or no female partner) (X)
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Item
    Did the subject complete the study as planned?
    text
    C2983670 (UMLS CUI [1,1])
    C2986196 (UMLS CUI [1,2])
    Subject completed study
    Code List
    Did the subject complete the study as planned?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If subject did not complete the study, please mark the one most appropriate category
    integer
    C3827242 (UMLS CUI [1])
    undefined item
    Code List
    If subject did not complete the study, please mark the one most appropriate category
    CL Item
    Adverse experience  (1)
    CL Item
    Protocol deviation (including non-compliance) (2)
    CL Item
    Lost to follow-up (3)
    CL Item
    Other (4)
    Other reason
    Item
    If other reason, please specify
    text
    C3840932 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Comments
    Item
    Comments on reason for withdrawal
    text
    C0947611 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Date of Withdrawal
    Item
    Date of Withdrawal
    date
    C2349954 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of Withdrawal
    Item
    Time of Withdrawal
    time
    C2349954 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Date of Final Dose
    Item
    Date of Final Dose
    date
    C1762893 (UMLS CUI [1])
    Time of Final Dose
    Item
    Time of Final Dose
    time
    C0946444 (UMLS CUI [1])
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