ID

28849

Description

Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: End of Study

Keywords

Versions (1)
  1. 2/8/18 2/8/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 8, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723

English

End of Study

1 forms  
  1. StudyEvent: ODM
    1. End of Study
Status Of Treatment Blind
Description

Status Of Treatment Blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Center
Description

Center

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Initials
Description

Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Was the treatment blind broken during the study?
Description

Treatment Blind

Data type

boolean

Alias
UMLS CUI [1]
C3897431
If 'Yes' complete the following: Reason?
Description

Reason Treatment Blind broken

Data type

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If Other, please specify
Description

Reason Treatment Blind broken

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Description

pregnant

Data type

integer

Alias
UMLS CUI [1]
C0032961
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Data type

date

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Was the subject withdrawn from the study?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

subject withdrawn

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Primary reason for withdrawal
Description

Primary reason for withdrawal

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Primary reason for withdrawal. If Other, please specify
Description

Primary reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
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Similar models

End of Study

1 forms
  1. StudyEvent: ODM
    1. End of Study
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Status Of Treatment Blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Treatment Blind
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Item
If 'Yes' complete the following: Reason?
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason Treatment Blind broken
Code List
If 'Yes' complete the following: Reason?
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (2)
Reason Treatment Blind broken
Item
If Other, please specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
pregnant
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
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
subject withdrawn
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
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
Insufficient therapeutic effect (6)
CL Item
Did not meet treatment eligibility criteria (7)
CL Item
Other (8)
Primary reason for withdrawal
Item
Primary reason for withdrawal. If Other, please specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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