ID

20063

Descripción

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.

Palabras clave

  1. 31/12/16 31/12/16 -
  2. 4/2/17 4/2/17 -
Subido en

4 de febrero de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0

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Screen Failure Log: Screening Failure [SF_1] NCT01117584

Screen Failure Log: Screening Failure [SF_1] NCT01117584

General Information
Descripción

General Information

Birth Date
Descripción

Birth Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Age
Descripción

Age

Tipo de datos

integer

Alias
UMLS CUI [1]
C0001779
Age Unit
Descripción

Age Unit

Tipo de datos

boolean

Sex
Descripción

Sex

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Race
Descripción

Race

Tipo de datos

text

Alias
UMLS CUI [1]
C0034510
If Other, please specify
Descripción

Other

Tipo de datos

text

Ethnicity
Descripción

Ethnicity

Tipo de datos

text

Alias
UMLS CUI [1]
C0015031
Reason for not meeting admission criteria
Descripción

Reason for not meeting admission criteria

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0582450
UMLS CUI [1,2]
C0243161
If Other, please specify
Descripción

Other

Tipo de datos

text

FPG > 270 mg/dL on 2 consecutive measurements
Descripción

If Reason is "Not meet inclusion/exclusion criteria", select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
FPG > 350 mg/dL
Descripción

FPG > 350 mg/dL

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
FPG < 40 mg/dL
Descripción

FPG < 40 mg/dL

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
Other Inclusion/Exclusion Criteria Not Met, please specify
Descripción

Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0680252
UMLS CUI [1,2]
C0243161

Similar models

Screen Failure Log: Screening Failure [SF_1] NCT01117584

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
General Information
Birth Date
Item
Birth Date
date
C0421451 (UMLS CUI [1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Age Unit
Item
Age Unit
boolean
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Code List
Race
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
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Code List
Ethnicity
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])
Code List
Reason for not meeting admission criteria
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])

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