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ID

24534

Description

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Follow-Up Laboratory Collections, Pregnancy Information, Study Conclusion

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Versions (1)
  1. 8/5/17 8/5/17 -
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GlaxoSmithKline

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August 5, 2017

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Creative Commons BY-NC 3.0
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    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Laboratory Collections, Pregnancy Information, Study Conclusion

    English

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Laboratory Collections, Pregnancy Information, Study Conclusion

    1 forms  
    Clinical Chemistry And Haematology
    Description

    Clinical Chemistry And Haematology

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-2
    C0018941
    Exact date and time of blood sampling
    Description

    blood sampling date and time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Comments:
    Description

    comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Are there CLINICALLY SIGNIFCANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
    Description

    clinical chemistry and hematology normal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0205307
    UMLS CUI [2,1]
    C0018941
    UMLS CUI [2,2]
    C0205307
    Pregnancy Information
    Description

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did patient become pregnant during the study?
    Description

    If YES, record details on Pregnancy Notification Form.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032961
    Did the female partner of a male patient become pregnant during the study?
    Description

    If YES, record details on Pregnancy Notification Form.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0919624
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Did the subject complete the study as planned?
    Description

    study completed

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348577
    If NO, mark the most appropriate category
    Description

    withdrawal reason

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C1549995
    If OTHER, please specify
    Description

    withdrawal reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C1549995
    Comments on reason for withdrawal:
    Description

    withdrawal reason comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    Date of Withdrawal
    Description

    withdrawal date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0011008
    Time of Withdrawal
    Description

    withdrawal time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0040223
    Date of Final Dose
    Description

    final dose date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1531784
    Time of Final Dose
    Description

    final dose time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1522314
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    Similar models

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Laboratory Collections, Pregnancy Information, Study Conclusion

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Clinical Chemistry And Haematology
    C0008000 (UMLS CUI-1)
    C0018941 (UMLS CUI-2)
    blood sampling date and time
    Item
    Exact date and time of blood sampling
    datetime
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    comments
    Item
    Comments:
    text
    C0947611 (UMLS CUI [1])
    clinical chemistry and hematology normal
    Item
    Are there CLINICALLY SIGNIFCANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
    boolean
    C0008000 (UMLS CUI [1,1])
    C0205307 (UMLS CUI [1,2])
    C0018941 (UMLS CUI [2,1])
    C0205307 (UMLS CUI [2,2])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did patient become pregnant during the study?
    text
    C0032961 (UMLS CUI [1])
    pregnancy
    Code List
    Did patient 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])
    pregnancy of partner
    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 female partner) (X)
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    study completed
    Item
    Did the subject complete the study as planned?
    boolean
    C2348577 (UMLS CUI [1])
    Item
    If NO, mark the most appropriate category
    integer
    C2349954 (UMLS CUI [1,1])
    C1549995 (UMLS CUI [1,2])
    withdrawal reason
    Code List
    If NO, mark the most appropriate category
    CL Item
    Adverse Event (complete Adverse Event Form) (1)
    CL Item
    Insufficient therapeutic effect (2)
    CL Item
    Deviation from Protocol (including non-compliance) (3)
    CL Item
    Lost to Follow-Up (4)
    CL Item
    Other (5)
    withdrawal reason
    Item
    If OTHER, please specify
    text
    C2349954 (UMLS CUI [1,1])
    C1549995 (UMLS CUI [1,2])
    withdrawal reason comment
    Item
    Comments on reason for withdrawal:
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    withdrawal date
    Item
    Date of Withdrawal
    date
    C2349954 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    withdrawal time
    Item
    Time of Withdrawal
    time
    C2349954 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    final dose date
    Item
    Date of Final Dose
    date
    C1531784 (UMLS CUI [1])
    final dose time
    Item
    Time of Final Dose
    time
    C0013227 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
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