0 Evaluaciones
ID

38776

Descripción

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

Palabras clave

Versiones (1)
  1. 3/11/19 3/11/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

3 de noviembre de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

    Inglés

    Study Conclusion

    1 formularios  
    1. StudyEvent: ODM
      1. Study Conclusion
    Study Conclusion
    Descripción

    Study Conclusion

    Alias
    UMLS CUI-1
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI-2
    C1707478 (Conclusion)
    Date of last contact
    Descripción

    Date last contact

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0805839 (Date last contact)
    LOINC
    MTHU010432
    Was the subject withdrawn from the study?
    Descripción

    Patient withdrawn from trial

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    Yes, Date of decision to withdraw
    Descripción

    Patient withdrawn from trial, Decision, Date in time

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C0679006 (Decision)
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Yes, Primary reason for withdrawal
    Descripción

    Patient withdrawn from trial, Reason and justification, Primary

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,3]
    C0205225 (Primary)
    SNOMED
    63161005
    LOINC
    LA21208-6
    Specify
    Descripción

    Patient withdrawn from trial, Reason and justification, Primary

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,3]
    C0205225 (Primary)
    SNOMED
    63161005
    LOINC
    LA21208-6
    Case book ready for signature
    Descripción

    Clinical Study Case, Signature

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1706256 (Clinical Study Case)
    UMLS CUI [1,2]
    C1519316 (Signature)
    LOINC
    LP248948-4
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    Similar models

    Study Conclusion

    1 formularios
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Patient withdrawn from trial, Reason and justification, Primary
    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])
    Volver a la parte superior de la página 

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