ID

25888

Descrição

A 24 week double-blind, randomised, placebo-controlled, parallel-group dose-ranging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer's disease.

Palavras-chave

Versões (1)
  1. 25/09/2017 25/09/2017 -
Titular dos direitos

Glaxo Smith Kline

Transferido a

25 de setembro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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GSK AVA100193 Rosiglitazone in Alzheimer´s Disease - Study Conclusion

Inglês

Study Conclusion

1 Formulários  
  1. StudyEvent: ODM
    1. Study Conclusion
Study Conclusion
Descrição

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Pregnancy Information: Check that responses provided correspond with the sex of the subject.
Descrição

Monitor Data Validation Check

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C1516647
UMLS CUI [1,3]
C0032961
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Did the subject become pregnant during the study?
Descrição

Pregnancy

Tipo de dados

text

Alias
UMLS CUI [1]
C0032961
Was the treatment blind broken during the study?
Descrição

Was the treatment blind broken during the study?

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C3897431
Date blind broken
Descrição

Date blind broken

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3899531
Reason blind broken
Descrição

Reason blind broken

Tipo de dados

text

Alias
UMLS CUI [1]
C0392360
Specify other reason for unblinding
Descrição

Reason blind broken

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C3845569
A medically qualified Sub-investigator may sign this page; however, the Investigator remains accountable for CRF data.
Descrição

Investigator Instructions

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1442085
Refer to protocol section(s) (insert protocol section number(s)) to evaluate subject completion or withdrawal from the study. • If subject completed study: Date of subject completion or withdrawal must match the last scheduled study visit date. • If subject withdrew and a withdrawal visit was conducted: Date of subject completion or withdrawal must match the date of subject withdrawal. • If subject lost to follow-up: Date of subject completion or withdrawal must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. • Adverse event: includes adverse events, serious adverse events, death (see protocol section 10). • Protocol violation: includes use of prohibited/conditional medications (see protocol section 8.2). • Subject decided to withdraw from the study: includes caregiver decision to withdraw the subject. • Non-compliance: includes non-compliance with study medication (see protocol section 7.11 ), or with study visits/ procedures.
Descrição

Note: An 'actual contact' is defined as an interaction between the subject and the investigator or investigator's designee, where the investigator/designee has the opportunity to query the subject about the subject's status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C1442085
Date of subject completion or withdrawal
Descrição

Date of subject completion or withdrawal

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0805732
UMLS CUI [1,3]
C2349954
Was the subject withdrawn from the study?
Descrição

Was the subject withdrawn from the study?

Tipo de dados

text

Alias
UMLS CUI [1]
C0422727
What was the primary reason for withdrawal?
Descrição

Withdrawal reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1549995
If OTHER, please specify
Descrição

withdrawal reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1549995
Investigator Signature
Descrição

Investigator Signature

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Printed Investigators name
Descrição

Investigator name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
Date
Descrição

Date of completion

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0850287
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Similar models

Study Conclusion

1 Formulários
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Monitor Data Validation Check
Item
Pregnancy Information: Check that responses provided correspond with the sex of the subject.
text
C1519941 (UMLS CUI [1,1])
C1516647 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Did the subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Complete the Pregnancy Notification form) (Y)
CL Item
Not Applicable (not of childbearing potential or male) (X)
Item
Was the treatment blind broken during the study?
text
C2347038 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
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])
C3899531 (UMLS CUI [1,2])
Item
Reason blind broken
text
C0392360 (UMLS CUI [1])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other,specify (2)
Reason blind broken
Item
Specify other reason for unblinding
text
C3897431 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Investigator Instructions
Item
A medically qualified Sub-investigator may sign this page; however, the Investigator remains accountable for CRF data.
text
C0008961 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Study Conclusion Investigator Instructions
Item
Refer to protocol section(s) (insert protocol section number(s)) to evaluate subject completion or withdrawal from the study. • If subject completed study: Date of subject completion or withdrawal must match the last scheduled study visit date. • If subject withdrew and a withdrawal visit was conducted: Date of subject completion or withdrawal must match the date of subject withdrawal. • If subject lost to follow-up: Date of subject completion or withdrawal must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. • Adverse event: includes adverse events, serious adverse events, death (see protocol section 10). • Protocol violation: includes use of prohibited/conditional medications (see protocol section 8.2). • Subject decided to withdraw from the study: includes caregiver decision to withdraw the subject. • Non-compliance: includes non-compliance with study medication (see protocol section 7.11 ), or with study visits/ procedures.
text
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,3])
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1,1])
C0805732 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Was the treatment blind broken during the study?
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
What was the primary reason for withdrawal?
text
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Withdrawal reason
Code List
What was the primary reason for withdrawal?
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate) (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 (6)
CL Item
Non-compliance (17)
CL Item
Other, specify (Z)
withdrawal reason
Item
If OTHER, please specify
text
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Printed Investigators name
text
C2826892 (UMLS CUI [1])
Date of completion
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
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