ID

17836

Beschreibung

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.

Stichworte

Versionen (2)
  1. 04.10.16 04.10.16 -
  2. 09.12.16 09.12.16 -
Hochgeladen am

4. Oktober 2016

DOI

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

Englisch

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

1 Formulare  
General Information
Beschreibung

General Information

Protocol Identifier: AVA100193
Beschreibung

Protocol Identifier

Datentyp

boolean

Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Visit Description: Study Conclusion
Beschreibung

Visit Description

Datentyp

boolean

Pregnancy Information
Beschreibung

Pregnancy Information

Did the subject become pregnant during the study?
Beschreibung

Did the subject become pregnant during the study?

Datentyp

text

Status of Treatment Blind
Beschreibung

Status of Treatment Blind

Was the treatment blind broken during the study?
Beschreibung

Was the treatment blind broken during the study?

Datentyp

text

Alias
UMLS CUI [1]
C2347038
Date blind broken
Beschreibung

Date blind broken

Datentyp

date

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

Reason

Datentyp

text

If Other, please specify
Beschreibung

Other

Datentyp

text

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

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

Datentyp

boolean

Study conclusion
Beschreibung

Study conclusion

Date of subject completion or withdrawal
Beschreibung

Date of subject completion or withdrawal

Datentyp

date

Was the subject withdrawn from the study?
Beschreibung

Was the subject withdrawn from the study?

Datentyp

boolean

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

Reason for withdrawal

Datentyp

text

If other, please specify
Beschreibung

Specification of Other

Datentyp

text

Investigator´s signature
Beschreibung

Investigator´s signature

Investigator´s signature
Beschreibung

Investigator´s signature

Datentyp

text

Investigator´s name (print)
Beschreibung

Investigator´s name (print)

Datentyp

text

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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
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