ID

24291

Description

Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Study Conclusion

Mots-clés

Versions (1)
  1. 28/07/2017 28/07/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

28 juillet 2017

DOI

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Licence

Creative Commons BY-NC-ND 3.0
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Study Conclusion GSK Rosiglitazone Alzheimer's disease 100468

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Study Conclusion GSK Rosiglitazone Alzheimer's disease 100468

1 Formulaires  
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Subject Identifier
Description

Subject Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Pregnancy Information
Description

Pregnancy Information

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

If Yes, complete Pregnancy Notification form.

Type de données

text

Alias
UMLS CUI [1]
C0032961
Study Conclusion
Description

Study Conclusion

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

Completion, Withdrawal

Type de données

date

Unités de mesure
  • dd-mmm-yy
Alias
UMLS CUI [1]
C0805732
UMLS CUI [2]
C2349954
dd-mmm-yy
Was the subject withdrawn from the study?
Description

* If YES, specify the primary reason.

Type de données

text

Alias
UMLS CUI [1]
C2349954
If Yes, tick the primary reason for withdrawal:
Description

Primary Reason of Withdrawal

Type de données

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1549995
If Yes, tick the primary reason for withdrawal: If Other, specify:
Description

Primary Reason of Withdrawal Specification

Type de données

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1549995
UMLS CUI [1,3]
C2348235
Investigator's Signature
Description

Investigator's Signature

Alias
UMLS CUI-1
C2346576
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator's name (print)
Description

Investigature's name

Type de données

text

Alias
UMLS CUI [1]
C2346576
Date of Report
Description

Date of Report

Type de données

date

Unités de mesure
  • dd-mmm-yy
Alias
UMLS CUI [1]
C1302584
dd-mmm-yy
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Similar models

Study Conclusion GSK Rosiglitazone Alzheimer's disease 100468

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (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
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (not of childbearing potential or male) (X)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
Completion, Withdrawal
Item
Date of subject completion or withdrawal
date
C0805732 (UMLS CUI [1])
C2349954 (UMLS CUI [2])
Item
Was the subject withdrawn from the study?
text
C2349954 (UMLS CUI [1])
Withdrawn
Code List
Was the subject withdrawn from the study?
CL Item
Yes* (Y)
CL Item
No (N)
Item
If Yes, tick the primary reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Primary Reason of Withdrawal
Code List
If Yes, tick the primary reason for withdrawal:
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropirate) (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 (Z)
Primary Reason of Withdrawal Specification
Item
If Yes, tick the primary reason for withdrawal: If Other, specify:
text
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigature's name
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator's name (print)
text
C2346576 (UMLS CUI [1])
Date of Report
Item
Date of Report
date
C1302584 (UMLS CUI [1])
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