ID

20054

Descrição

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.

Palavras-chave

  1. 30/12/2016 30/12/2016 -
  2. 04/02/2017 04/02/2017 -
Transferido a

4 de fevereiro de 2017

DOI

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Licença

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
Descrição

General Information

Date of Last Treatment Evaluation Through Visit 7
Descrição

Date of Collection

Tipo de dados

datetime

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

Study day of collection

Tipo de dados

text

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

Complete Study Drug Treatment

Tipo de dados

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.
Descrição

Study Drug Treatment

Tipo de dados

text

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

End of Treatment

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0444930
If reason is `Withdrawal by Subject` please speficy follow-up allowance
Descrição

Withdrawal by subject

Tipo de dados

integer

Alias
UMLS CUI [1]
C0589120
Date of Withdrawal
Descrição

Date of Withdrawal

Tipo de dados

date

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

Result in Death

Tipo de dados

text

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

Protocol Violation

Tipo de dados

text

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

Other

Tipo de dados

text

Similar models

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

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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