ID

17678

Description

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes Mellitus End of Study

Keywords

Versions (2)
  1. 8/15/16 8/15/16 -
  2. 9/28/16 9/28/16 -
Uploaded on

September 28, 2016

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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End of Study Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

English

End of Study Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

1 forms  
End of Treatment / Premature Discontinuation
Description

End of Treatment / Premature Discontinuation

Alias
UMLS CUI-1
C0580352
UMLS CUI-3
C0457454
Date of Last Treatment Evaluation Through Visit 9
Description

Date of Collection

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Did subject complete Study Drug Treatment?
Description

Complete Study Drug Treatment

Data type

boolean

Alias
UMLS CUI [1]
C0013216
End of Treatment Reason
Description

End of Treatment Reason

Data type

integer

Alias
UMLS CUI [1]
C0457454
If reason is "Withdrawal by Subject" please speficy follow-up allowance
Description

Withdrawal by subject

Data type

integer

Alias
UMLS CUI [1]
C0589120
Date of Withdrawal
Description

Date of Withdrawal

Data type

date

Measurement units
  • dd/MMM/yyyy
Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0011008
dd/MMM/yyyy
Did AE result in death?
Description

AE Result in death

Data type

integer

Alias
UMLS CUI [1]
C0011065
If protocol violation, specify
Description

Protocol Violation

Data type

text

Alias
UMLS CUI [1]
C1709750
If Other, specify
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
End of Study
Description

End of Study

Alias
UMLS CUI-1
C0444496
Date of Last Evaluation
Description

Date of collection

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
End of Study Assessment
Description

End of Study Assessment

Data type

integer

Alias
UMLS CUI [1]
C0220825
Details of Withdrawal
Description

Details of Withdrawal

Data type

text

Alias
UMLS CUI [1]
C2349954
If Other specify
Description

Other

Data type

text

Alias
UMLS CUI [1]
C2349954
UMLS CUI [2]
C0205394
Mortality Report
Description

Mortality Report

Alias
UMLS CUI-1
C0011065
Date of Death
Description

Date of Death

Data type

date

Alias
UMLS CUI [1]
C0011065
Cause of Death
Description

Cause of Death

Data type

text

Alias
UMLS CUI [1]
C0007465
Relationship of Study Drug to Subject's Death?
Description

Relationship to Study Drug

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0304229
Was autopsy performed?
Description

Autopsy

Data type

integer

Alias
UMLS CUI [1]
C0004398
Breaking the Blind
Description

Breaking the Blind

Alias
UMLS CUI-1
C2347038
Was Blind Broken During the Study?
Description

Blind Broken

Data type

boolean

Alias
UMLS CUI [1]
C2347038
Date blind broken
Description

Date blind broken

Data type

date

Alias
UMLS CUI [1]
C0011008
UMLS CUI [2]
C2347038
Time Blind Broken
Description

Time Blind Broken

Data type

time

Alias
UMLS CUI [1]
C2347038
UMLS CUI [2]
C0040223
Person who requested blind to be broken
Description

Person Blind Broken

Data type

text

Alias
UMLS CUI [1]
C2347038
Person who broke the blind
Description

Person who broke the blind

Data type

text

Alias
UMLS CUI [1]
C2347038
Person contacted at Astellas
Description

Person contacted at Astellas

Data type

text

Alias
UMLS CUI [1]
C2347038
Reason for breaking the blind
Description

Reason for breaking the blind

Data type

text

Alias
UMLS CUI [1]
C2347038
UMLS CUI [2]
C0566251
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Similar models

End of Study Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
End of Treatment / Premature Discontinuation
C0580352 (UMLS CUI-1)
C0457454 (UMLS CUI-3)
Date of Collection
Item
Date of Last Treatment Evaluation Through Visit 9
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Complete Study Drug Treatment
Item
Did subject complete Study Drug Treatment?
boolean
C0013216 (UMLS CUI [1])
Item
End of Treatment Reason
integer
C0457454 (UMLS CUI [1])
End of Treatment Reason
Code List
End of Treatment Reason
CL Item
Not fulfill inclusion or exclusion criteria (1)
CL Item
adverse event (2)
CL Item
lack of efficacy (3)
CL Item
withdrawal by subject (4)
CL Item
subject lost to follow up (5)
CL Item
protocol violation (6)
CL Item
randomized/registered but never received/dispensed study drug (7)
CL Item
other (8)
Item
If reason is "Withdrawal by Subject" please speficy follow-up allowance
integer
C0589120 (UMLS CUI [1])
Withdrawal by subject
Code List
If reason is "Withdrawal by Subject" please speficy follow-up allowance
CL Item
allows follow-up after withdrawal (1)
CL Item
does not allow follow-up after withdrawal (2)
Date of Withdrawal
Item
Date of Withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Did AE result in death?
integer
C0011065 (UMLS CUI [1])
AE Result in death
Code List
Did AE result in death?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Protocol Violation
Item
If protocol violation, specify
text
C1709750 (UMLS CUI [1])
Other
Item
If Other, specify
text
C0205394 (UMLS CUI [1])
Item Group
End of Study
C0444496 (UMLS CUI-1)
Date of collection
Item
Date of Last Evaluation
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
End of Study Assessment
integer
C0220825 (UMLS CUI [1])
End of Study Assessment
Code List
End of Study Assessment
CL Item
Completed (1)
CL Item
Death (2)
CL Item
Lost to Follow-up (3)
CL Item
Withdrawal by Subject (4)
CL Item
Not Applicable (5)
CL Item
Other (6)
Details of Withdrawal
Item
Details of Withdrawal
text
C2349954 (UMLS CUI [1])
Other
Item
If Other specify
text
C2349954 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
Item Group
Mortality Report
C0011065 (UMLS CUI-1)
Date of Death
Item
Date of Death
date
C0011065 (UMLS CUI [1])
Cause of Death
Item
Cause of Death
text
C0007465 (UMLS CUI [1])
Item
Relationship of Study Drug to Subject's Death?
integer
C0877248 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Relationship to Study Drug
Code List
Relationship of Study Drug to Subject's Death?
CL Item
Not related (1)
CL Item
Possible (2)
CL Item
Probable (3)
Item
Was autopsy performed?
integer
C0004398 (UMLS CUI [1])
Autopsy
Code List
Was autopsy performed?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item Group
Breaking the Blind
C2347038 (UMLS CUI-1)
Blind Broken
Item
Was Blind Broken During the Study?
boolean
C2347038 (UMLS CUI [1])
Date blind broken
Item
Date blind broken
date
C0011008 (UMLS CUI [1])
C2347038 (UMLS CUI [2])
Time Blind Broken
Item
Time Blind Broken
time
C2347038 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
Person Blind Broken
Item
Person who requested blind to be broken
text
C2347038 (UMLS CUI [1])
Person who broke the blind
Item
Person who broke the blind
text
C2347038 (UMLS CUI [1])
Person contacted at Astellas
Item
Person contacted at Astellas
text
C2347038 (UMLS CUI [1])
Reason for breaking the blind
Item
Reason for breaking the blind
text
C2347038 (UMLS CUI [1])
C0566251 (UMLS CUI [2])
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