ID

16942

Beschrijving

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 MellitusTEST Study End of Study

Trefwoorden

Versies (2)
  1. 15-08-16 15-08-16 -
  2. 28-09-16 28-09-16 -
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15 augustus 2016

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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DM-ASP1941-1941-CL-0004 NCT01071850

Engels

End of Study DM-ASP1941-1941-CL-0004 NCT01071850

1 Formulieren  
End of Treatment / Premature Discontinuation
Beschrijving

End of Treatment / Premature Discontinuation

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

Date of Collection

Datatype

date

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

Complete Study Drug Treatment

Datatype

boolean

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

End of Treatment Reason

Datatype

integer

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

Withdrawal by subject

Datatype

integer

Alias
UMLS CUI [1]
C0589120
Date of Withdrawal
Beschrijving

Date of Withdrawal

Datatype

date

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

AE Result in death

Datatype

integer

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

Protocol Violation

Datatype

text

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

Other

Datatype

text

Alias
UMLS CUI [1]
C0205394
End of Study
Beschrijving

End of Study

Alias
UMLS CUI-1
C0444496
Date of Last Evaluation
Beschrijving

Date of collection

Datatype

date

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

End of Study Assessment

Datatype

integer

Alias
UMLS CUI [1]
C0220825
Details of Withdrawal
Beschrijving

Details of Withdrawal

Datatype

text

Alias
UMLS CUI [1]
C2349954
If Other specify
Beschrijving

Other

Datatype

text

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

Mortality Report

Alias
UMLS CUI-1
C0011065
Date of Death
Beschrijving

Date of Death

Datatype

date

Alias
UMLS CUI [1]
C0011065
Cause of Death
Beschrijving

Cause of Death

Datatype

text

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

Relationship to Study Drug

Datatype

integer

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

Autopsy

Datatype

integer

Alias
UMLS CUI [1]
C0004398
Breaking the Blind
Beschrijving

Breaking the Blind

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

Blind Broken

Datatype

boolean

Alias
UMLS CUI [1]
C2347038
Date blind broken
Beschrijving

Date blind broken

Datatype

date

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

Time Blind Broken

Datatype

time

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

Person Blind Broken

Datatype

text

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

Person who broke the blind

Datatype

text

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

Person contacted at Astellas

Datatype

text

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

Reason for breaking the blind

Datatype

text

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

End of Study DM-ASP1941-1941-CL-0004 NCT01071850

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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