ID

17836

Description

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.

Mots-clés

Versions (2)
  1. 04/10/2016 04/10/2016 -
  2. 09/12/2016 09/12/2016 -
Téléchargé le

4 octobre 2016

DOI

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

Anglais

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

1 Formulaires  
General Information
Description

General Information

Protocol Identifier: AVA100193
Description

Protocol Identifier

Type de données

boolean

Subject Identifier
Description

Subject Identifier

Type de données

integer

Visit Description: Study Conclusion
Description

Visit Description

Type de données

boolean

Pregnancy Information
Description

Pregnancy Information

Did the subject become pregnant during the study?
Description

Did the subject become pregnant during the study?

Type de données

text

Status of Treatment Blind
Description

Status of Treatment Blind

Was the treatment blind broken during the study?
Description

Was the treatment blind broken during the study?

Type de données

text

Alias
UMLS CUI [1]
C2347038
Date blind broken
Description

Date blind broken

Type de données

date

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

Reason

Type de données

text

If Other, please specify
Description

Other

Type de données

text

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

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

Type de données

boolean

Study conclusion
Description

Study conclusion

Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Type de données

date

Was the subject withdrawn from the study?
Description

Was the subject withdrawn from the study?

Type de données

boolean

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

Reason for withdrawal

Type de données

text

If other, please specify
Description

Specification of Other

Type de données

text

Investigator´s signature
Description

Investigator´s signature

Investigator´s signature
Description

Investigator´s signature

Type de données

text

Investigator´s name (print)
Description

Investigator´s name (print)

Type de données

text

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Similar models

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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
Retour au début de la page 

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