Information:
Error:
ID
20063
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
Versions (2)
- 12/31/16 12/31/16 -
- 2/4/17 2/4/17 -
Uploaded on
February 4, 2017
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Screen Failure Log: Screening Failure [SF_1] NCT01117584
Screen Failure Log: Screening Failure [SF_1] NCT01117584
- StudyEvent: ODM
Similar models
Screen Failure Log: Screening Failure [SF_1] NCT01117584
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Birth Date
Item
Birth Date
date
C0421451 (UMLS CUI [1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Age Unit
Item
Age Unit
boolean
CL Item
Male (1)
CL Item
Female (2)
CL Item
White (1)
CL Item
Black or African American (2)
CL Item
Asian (3)
CL Item
Amerikan Indian or Alaska Native (4)
CL Item
Native Hawaiian or Other Pacific Islander (5)
CL Item
Other (6)
Other
Item
If Other, please specify
text
CL Item
Not Hispanic or Latino (1)
CL Item
Hispanic or Latino (2)
Item
Reason for not meeting admission criteria
text
C0582450 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,2])
CL Item
Not fulfill inclusion or exclusion criteria (1)
CL Item
Adverse Event (2)
CL Item
Withdrawal of consent (3)
CL Item
Subject lost to follow up (4)
CL Item
Other (5)
Other
Item
If Other, please specify
text
FPG > 270 mg/dL on 2 consecutive measurements
Item
FPG > 270 mg/dL on 2 consecutive measurements
boolean
C0583513 (UMLS CUI [1])
FPG > 350 mg/dL
Item
FPG > 350 mg/dL
boolean
C0583513 (UMLS CUI [1])
FPG < 40 mg/dL
Item
FPG < 40 mg/dL
boolean
C0583513 (UMLS CUI [1])
Specification
Item
Other Inclusion/Exclusion Criteria Not Met, please specify
text
C0680252 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,2])