Informações:
Falhas:
ID
19170
Descrição
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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Versões (2)
- 04/10/2016 04/10/2016 -
- 09/12/2016 09/12/2016 -
Transferido a
9 de dezembro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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M.Alzheimer GSK - Study Conclusion NCT00334568/ GSK-AVA100193
M.Alzheimer GSK - Study Conclusion NCT00334568/ GSK-AVA100193
- StudyEvent: ODM
Similar models
M.Alzheimer GSK - Study Conclusion NCT00334568/ GSK-AVA100193
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Description
Item
Visit Description: Study Conclusion
boolean
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
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
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
C2347038 (UMLS CUI-2)
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])
C2347038 (UMLS CUI [1,2])
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
C2347038 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Non-Serious Adverse Event, Serious Adverse Event and/or Investigational Product
Item
Complete Non-Serious Adverse Event, Serious Adverse Event and/or Investigational Product pages, as appropriate.
boolean
C1518404 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C0304229 (UMLS CUI [3])
C1519255 (UMLS CUI [2])
C0304229 (UMLS CUI [3])
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Withdrawl
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If yes, select the primary (!) reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
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
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Investigator´s signature
Item
Investigator´s signature
text
C2346576 (UMLS CUI [1])
Investigator´s name
Item
Investigator´s name (print)
text
C2361125 (UMLS CUI [1])