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
UMLS CUI-2
C1707478
Date of last contact
Descripción

Date last contact

Tipo de datos

date

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Was the subject withdrawn from the study?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

Patient withdrawn from trial

Tipo de datos

boolean

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Patient withdrawn from trial, Decision, Date in time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

Patient withdrawn from trial, Reason and justification, Primary

Tipo de datos

text

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

Patient withdrawn from trial, Reason and justification, Primary

Tipo de datos

text

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

Clinical Study Case, Signature

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C1519316
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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Patient withdrawn from trial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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