ID

17836

Beschrijving

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.

Trefwoorden

  1. 04-10-16 04-10-16 -
  2. 09-12-16 09-12-16 -
Geüploaded op

4 oktober 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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

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

General Information
Beschrijving

General Information

Protocol Identifier: AVA100193
Beschrijving

Protocol Identifier

Datatype

boolean

Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Visit Description: Study Conclusion
Beschrijving

Visit Description

Datatype

boolean

Pregnancy Information
Beschrijving

Pregnancy Information

Did the subject become pregnant during the study?
Beschrijving

Did the subject become pregnant during the study?

Datatype

text

Status of Treatment Blind
Beschrijving

Status of Treatment Blind

Was the treatment blind broken during the study?
Beschrijving

Was the treatment blind broken during the study?

Datatype

text

Alias
UMLS CUI [1]
C2347038
Date blind broken
Beschrijving

Date blind broken

Datatype

date

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

Reason

Datatype

text

If Other, please specify
Beschrijving

Other

Datatype

text

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

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

Datatype

boolean

Study conclusion
Beschrijving

Study conclusion

Date of subject completion or withdrawal
Beschrijving

Date of subject completion or withdrawal

Datatype

date

Was the subject withdrawn from the study?
Beschrijving

Was the subject withdrawn from the study?

Datatype

boolean

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

Reason for withdrawal

Datatype

text

If other, please specify
Beschrijving

Specification of Other

Datatype

text

Investigator´s signature
Beschrijving

Investigator´s signature

Investigator´s signature
Beschrijving

Investigator´s signature

Datatype

text

Investigator´s name (print)
Beschrijving

Investigator´s name (print)

Datatype

text

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
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])
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
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
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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