ID

17836

Descripción

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK A 24 week double-blind, randomized, placebo-controlled, parallel-group dose-raging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer´s disease. Medicine: rosiglitazone, Condition: Alzheimer´s Disease, Phase: 2, Clinical Study ID: AVA 100193, Sponsor: GSK. This ODM contains the Study Conclusion.

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Versiones (2)
  1. 4/10/16 4/10/16 -
  2. 9/12/16 9/12/16 -
Subido en

4 de octubre de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Study Conclusion

Inglés

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Study Conclusion

1 formularios  
General Information
Descripción

General Information

Protocol Identifier: AVA100193
Descripción

Protocol Identifier

Tipo de datos

boolean

Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Visit Description: Study Conclusion
Descripción

Visit Description

Tipo de datos

boolean

Pregnancy Information
Descripción

Pregnancy Information

Did the subject become pregnant during the study?
Descripción

Did the subject become pregnant during the study?

Tipo de datos

text

Status of Treatment Blind
Descripción

Status of Treatment Blind

Was the treatment blind broken during the study?
Descripción

Was the treatment blind broken during the study?

Tipo de datos

text

Alias
UMLS CUI [1]
C2347038
Date blind broken
Descripción

Date blind broken

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2347038
Reason blind broken
Descripción

Reason

Tipo de datos

text

If Other, please specify
Descripción

Other

Tipo de datos

text

Complete Non-Serious Adverse Event, Serious Adverse Event and/or Investigational Product pages, as appropriate.
Descripción

Complete Non-Serious Adverse Event, Serious Adverse Event and/or Investigational Product pages, as appropriate

Tipo de datos

boolean

Study conclusion
Descripción

Study conclusion

Date of subject completion or withdrawal
Descripción

Date of subject completion or withdrawal

Tipo de datos

date

Was the subject withdrawn from the study?
Descripción

Was the subject withdrawn from the study?

Tipo de datos

boolean

If yes, select the primary (!) reason for withdrawal
Descripción

Reason for withdrawal

Tipo de datos

text

If other, please specify
Descripción

Specification of Other

Tipo de datos

text

Investigator´s signature
Descripción

Investigator´s signature

Investigator´s signature
Descripción

Investigator´s signature

Tipo de datos

text

Investigator´s name (print)
Descripción

Investigator´s name (print)

Tipo de datos

text

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Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Study Conclusion

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
General Information
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
Subject Identifier
Item
Subject Identifier
integer
Visit Description
Item
Visit Description: Study Conclusion
boolean
Item Group
Pregnancy Information
Item
Did the subject become pregnant during the study?
text
Did the subject become pregnant during the study?
Code List
Did the subject become pregnant during the study?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (not of childbearing potential or male) (3)
Item Group
Status of Treatment Blind
Item
Was the treatment blind broken during the study?
text
C2347038 (UMLS CUI [1])
Was the treatment blind broken during the study?
Code List
Was the treatment blind broken during the study?
CL Item
No (N)
CL Item
Yes (Y)
Date blind broken
Item
Date blind broken
date
C0011008 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Item
Reason blind broken
text
Reason
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment  (1)
CL Item
Other (specify) (2)
Other
Item
If Other, please specify
text
Complete Non-Serious Adverse Event, Serious Adverse Event and/or Investigational Product pages, as appropriate
Item
Complete Non-Serious Adverse Event, Serious Adverse Event and/or Investigational Product pages, as appropriate.
boolean
Item Group
Study conclusion
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
Item
If yes, select the primary (!) reason for withdrawal
text
Reason for withdrawal
Code List
If yes, select the primary (!) reason for withdrawal
CL Item
Adverse event  (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (5)
CL Item
Non-compliance (6)
CL Item
Other (7)
Specification of Other
Item
If other, please specify
text
Item Group
Investigator´s signature
Investigator´s signature
Item
Investigator´s signature
text
Investigator´s name (print)
Item
Investigator´s name (print)
text
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