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ID

38776

Beschrijving

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Trefwoorden

  1. 03-11-19 03-11-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

3 november 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

    Study Conclusion

    1. StudyEvent: ODM
      1. Study Conclusion
    Study Conclusion
    Beschrijving

    Study Conclusion

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C1707478
    Date of last contact
    Beschrijving

    Date last contact

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0805839
    Was the subject withdrawn from the study?
    Beschrijving

    Patient withdrawn from trial

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Yes, Date of decision to withdraw
    Beschrijving

    Patient withdrawn from trial, Decision, Date in time

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0679006
    UMLS CUI [1,3]
    C0011008
    Yes, Primary reason for withdrawal
    Beschrijving

    Patient withdrawn from trial, Reason and justification, Primary

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0205225
    Specify
    Beschrijving

    Patient withdrawn from trial, Reason and justification, Primary

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0205225
    Case book ready for signature
    Beschrijving

    Clinical Study Case, Signature

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1706256
    UMLS CUI [1,2]
    C1519316

    Similar models

    Study Conclusion

    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Study Conclusion
    C0008976 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    Date last contact
    Item
    Date of last contact
    date
    C0805839 (UMLS CUI [1])
    Patient withdrawn from trial
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Patient withdrawn from trial, Decision, Date in time
    Item
    Yes, Date of decision to withdraw
    date
    C0422727 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Yes, Primary reason for withdrawal
    text
    C0422727 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0205225 (UMLS CUI [1,3])
    Code List
    Yes, 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 stopping criteria (4)
    CL Item
    Study closed/terminated (5)
    CL Item
    Lost to Follow-up (6)
    CL Item
    Investigator discretion, specify (7)
    CL Item
    Withdrew consent (8)
    Patient withdrawn from trial, Reason and justification, Primary
    Item
    Specify
    text
    C0422727 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0205225 (UMLS CUI [1,3])
    Clinical Study Case, Signature
    Item
    Case book ready for signature
    boolean
    C1706256 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])

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