ID

20054

Description

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Keywords

  1. 12/30/16 12/30/16 -
  2. 2/4/17 2/4/17 -
Uploaded on

February 4, 2017

DOI

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License

Creative Commons BY-NC 3.0

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End of Study: End of Treatment/ Premature Discontinuation [DS_1] NCT01117584

End of Study: End of Treatment/ Premature Discontinuation [DS_1] NCT01117584

General Information
Description

General Information

Date of Last Treatment Evaluation Through Visit 7
Description

Date of Collection

Data type

datetime

Alias
UMLS CUI [1,1]
C0557980
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
Study day of collection
Description

Study day of collection

Data type

text

Alias
UMLS CUI [1,1]
C0557980
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C2826182
Did subject complete Study Drug Treatment?
Description

Complete Study Drug Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0013216
UMLS CUI [1,4]
C0205197
If no, please provide details below.
Description

Study Drug Treatment

Data type

text

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C1522508
End of Treatment
Description

End of Treatment

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0444930
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

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0011008
Did AE result in death?
Description

Result in Death

Data type

text

Alias
UMLS CUI [1]
C1705232
If "Protocol Violation", please specify
Description

Protocol Violation

Data type

text

Alias
UMLS CUI [1]
C1709750
If "Other" please specify
Description

Other

Data type

text

Similar models

End of Study: End of Treatment/ Premature Discontinuation [DS_1] NCT01117584

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
Date of Collection
Item
Date of Last Treatment Evaluation Through Visit 7
datetime
C0557980 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Study day of collection
Item
Study day of collection
text
C0557980 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,3])
Complete Study Drug Treatment
Item
Did subject complete Study Drug Treatment?
boolean
C0008972 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Study Drug Treatment
Item
If no, please provide details below.
text
C0008972 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item
End of Treatment
text
C0087111 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
Code List
End of Treatment
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])
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?
text
C1705232 (UMLS CUI [1])
Code List
Did AE result in death?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Protocol Violation
Item
If "Protocol Violation", please specify
text
C1709750 (UMLS CUI [1])
Other
Item
If "Other" please specify
text

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