ID

17836

Descrizione

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.

Keywords

versioni (2)
  1. 04/10/16 04/10/16 -
  2. 09/12/16 09/12/16 -
Caricato su

4 ottobre 2016

DOI

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Licenza

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

Inglese

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

1 moduli  
General Information
Descrizione

General Information

Protocol Identifier: AVA100193
Descrizione

Protocol Identifier

Tipo di dati

boolean

Subject Identifier
Descrizione

Subject Identifier

Tipo di dati

integer

Visit Description: Study Conclusion
Descrizione

Visit Description

Tipo di dati

boolean

Pregnancy Information
Descrizione

Pregnancy Information

Did the subject become pregnant during the study?
Descrizione

Did the subject become pregnant during the study?

Tipo di dati

text

Status of Treatment Blind
Descrizione

Status of Treatment Blind

Was the treatment blind broken during the study?
Descrizione

Was the treatment blind broken during the study?

Tipo di dati

text

Alias
UMLS CUI [1]
C2347038
Date blind broken
Descrizione

Date blind broken

Tipo di dati

date

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

Reason

Tipo di dati

text

If Other, please specify
Descrizione

Other

Tipo di dati

text

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

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

Tipo di dati

boolean

Study conclusion
Descrizione

Study conclusion

Date of subject completion or withdrawal
Descrizione

Date of subject completion or withdrawal

Tipo di dati

date

Was the subject withdrawn from the study?
Descrizione

Was the subject withdrawn from the study?

Tipo di dati

boolean

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

Reason for withdrawal

Tipo di dati

text

If other, please specify
Descrizione

Specification of Other

Tipo di dati

text

Investigator´s signature
Descrizione

Investigator´s signature

Investigator´s signature
Descrizione

Investigator´s signature

Tipo di dati

text

Investigator´s name (print)
Descrizione

Investigator´s name (print)

Tipo di dati

text

Ritorna all'inizio della pagina

Similar models

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

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
Ritorna all'inizio della pagina 

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