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

1 forms  
General Information
Description

General Information

Protocol Identifier: AVA100193
Description

Protocol Identifier

Data type

boolean

Subject Identifier
Description

Subject Identifier

Data type

integer

Visit Description: Study Conclusion
Description

Visit Description

Data type

boolean

Pregnancy Information
Description

Pregnancy Information

Did the subject become pregnant during the study?
Description

Did the subject become pregnant during the study?

Data type

text

Status of Treatment Blind
Description

Status of Treatment Blind

Was the treatment blind broken during the study?
Description

Was the treatment blind broken during the study?

Data type

text

Alias
UMLS CUI [1]
C2347038
Date blind broken
Description

Date blind broken

Data type

date

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

Reason

Data type

text

If Other, please specify
Description

Other

Data type

text

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

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

Data type

boolean

Study conclusion
Description

Study conclusion

Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Data type

date

Was the subject withdrawn from the study?
Description

Was the subject withdrawn from the study?

Data type

boolean

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

Reason for withdrawal

Data type

text

If other, please specify
Description

Specification of Other

Data type

text

Investigator´s signature
Description

Investigator´s signature

Investigator´s signature
Description

Investigator´s signature

Data type

text

Investigator´s name (print)
Description

Investigator´s name (print)

Data type

text

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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