ID

19170

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

9 dicembre 2016

DOI

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Licenza

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

Inglese

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

1 moduli  
General Information
Descrizione

General Information

Alias
UMLS CUI-1
C1508263
Protocol Identifier: AVA100193
Descrizione

Protocol Identifier

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Descrizione

Subject Identifier

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Visit Description: Study Conclusion
Descrizione

Visit Description

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
Pregnancy Information
Descrizione

Pregnancy Information

Alias
UMLS CUI-1
C0032961
Did the subject become pregnant during the study?
Descrizione

Pregnancy

Tipo di dati

text

Alias
UMLS CUI [1]
C0032961
Status of Treatment Blind
Descrizione

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
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

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C0392360
If Other, please specify
Descrizione

Other

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C2348235
Complete Non-Serious Adverse Event, Serious Adverse Event and/or Investigational Product pages, as appropriate.
Descrizione

Non-Serious Adverse Event, Serious Adverse Event and/or Investigational Product

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2]
C1519255
UMLS CUI [3]
C0304229
Study conclusion
Descrizione

Study conclusion

Alias
UMLS CUI-1
C1707478
Date of subject completion or withdrawal
Descrizione

Date of subject completion or withdrawal

Tipo di dati

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from the study?
Descrizione

Withdrawl

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0422727
If yes, select the primary (!) reason for withdrawal
Descrizione

Reason for withdrawal

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
If other, please specify
Descrizione

Specification of Other

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C2348235
Investigator´s signature
Descrizione

Investigator´s signature

Alias
UMLS CUI-1
C2346576
Investigator´s signature
Descrizione

Investigator´s signature

Tipo di dati

text

Alias
UMLS CUI [1]
C2346576
Investigator´s name (print)
Descrizione

Investigator´s name

Tipo di dati

text

Alias
UMLS CUI [1]
C2361125
Ritorna all'inizio della pagina

Similar models

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

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
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])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
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
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
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
C2347038 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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
C2347038 (UMLS CUI [1,1])
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])
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
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])
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
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Investigator´s signature
C2346576 (UMLS CUI-1)
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])
Ritorna all'inizio della pagina 

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