ID

16917

Descripción

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 Visit 7, Visit 8

Palabras clave

Versiones (1)
  1. 14/8/16 14/8/16 -
Subido en

14 de agosto de 2016

DOI

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Licencia

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

Inglés

Visit 7, Visit 8 DM-ASP1941-1941-CL-0004 NCT01071850

1 formularios  
Date of Visit
Descripción

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit
Descripción

Visit date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Orthostatic Vital Signs
Descripción

Orthostatic Vital Signs

Alias
UMLS CUI-1
C0518766
Not done:
Descripción

Assessment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1516048
Assessment Date
Descripción

Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C2985720
Assessment Time
Descripción

Assessment Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0040223
Vital Signs
Descripción

Position

Tipo de datos

integer

Alias
UMLS CUI [1]
C0518766
Location of blood pressure measurement
Descripción

Location of blood pressure measurement

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005823
Systolic Blood Pressure
Descripción

Systolic Blood Pressure

Tipo de datos

text

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

text

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Descripción

Pulse Rate

Tipo de datos

text

Unidades de medida
  • Beats/min
Alias
UMLS CUI [1]
C0232117
Beats/min
ECG: 12 Lead ECG 1
Descripción

ECG: 12 Lead ECG 1

Alias
UMLS CUI-1
C0013798
Date ECG was performed
Descripción

ECG Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
ECG Time performed
Descripción

ECG time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
ECG Interpretation
Descripción

ECG Interpretation

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0459471
Weight
Descripción

Weight

Alias
UMLS CUI-1
C0005910
Assessment Date
Descripción

Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Weight
Descripción

Weight

Tipo de datos

text

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Waist and Hip Circumference
Descripción

Waist and Hip Circumference

Alias
UMLS CUI-1
C0455829
UMLS CUI-3
C0562350
Waist Circumference
Descripción

Waist Circumference

Tipo de datos

text

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0455829
cm
Hip Circumference
Descripción

Hip Circumference

Tipo de datos

text

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0562350
cm
Pregnancy Test
Descripción

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Select "Not done" if urine sample was not taken.
Descripción

Lab Status

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C2826677
Date of specimen collection
Descripción

Date of specimen collection

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
result pregnancy test
Descripción

result pregnancy test

Tipo de datos

integer

Alias
UMLS CUI [1]
C3259477
Meal Data
Descripción

Meal Data

Alias
UMLS CUI-1
C0016452
Date Food Intake
Descripción

Date Food Intake

Tipo de datos

date

Alias
UMLS CUI [1]
C0016452
Time of first food intake
Descripción

Start time of meal

Tipo de datos

time

Alias
UMLS CUI [1]
C0016452
Blood Sample
Descripción

Blood Sample

Alias
UMLS CUI-1
C0005834
Date of Dose of ASP1941 on Day of blood sampling
Descripción

Date of Dose

Tipo de datos

date

Alias
UMLS CUI [1]
C1762893
Time of Last Dose of Study Drug
Descripción

Time of Last Dose of Study Drug

Tipo de datos

time

Alias
UMLS CUI [1]
C0946444
Date of Dose of ASP1941 on day before blood sampling
Descripción

Date of Dose

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C0178602
Check if Sample Not Drawn or Not Sent to Lab
Descripción

Not Done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1272696
Date of Sample
Descripción

Date of Sample

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Sample Time
Descripción

Sample Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
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Similar models

Visit 7, Visit 8 DM-ASP1941-1941-CL-0004 NCT01071850

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Orthostatic Vital Signs
C0518766 (UMLS CUI-1)
Assessment
Item
Not done:
boolean
C0518766 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Assessment Date
Item
Assessment Date
date
C0518766 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Assessment Time
Item
Assessment Time
time
C0518766 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
integer
C0518766 (UMLS CUI [1])
Vital Signs
Code List
Vital Signs
CL Item
Sitting (Sitting)
CL Item
Standing (Standing)
Item
Location of blood pressure measurement
integer
C0005823 (UMLS CUI [1])
Location of blood pressure measurement
Code List
Location of blood pressure measurement
CL Item
Right Arm  (1)
CL Item
Left Arm (2)
Systolic Blood Pressure
Item
Systolic Blood Pressure
text
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
text
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse Rate
text
C0232117 (UMLS CUI [1])
Item Group
ECG: 12 Lead ECG 1
C0013798 (UMLS CUI-1)
ECG Date
Item
Date ECG was performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
ECG time
Item
ECG Time performed
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
ECG Interpretation
integer
C1623258 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])
ECG Interpretation
Code List
ECG Interpretation
CL Item
Normal  (0 )
CL Item
Abnormal - not clinically significant  (1 )
CL Item
Abnormal - clinically significant (2 )
Item Group
Weight
C0005910 (UMLS CUI-1)
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Weight
Item
Weight
text
C0005910 (UMLS CUI [1])
Item Group
Waist and Hip Circumference
C0455829 (UMLS CUI-1)
C0562350 (UMLS CUI-3)
Waist Circumference
Item
Waist Circumference
text
C0455829 (UMLS CUI [1])
Hip Circumference
Item
Hip Circumference
text
C0562350 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Item
Select "Not done" if urine sample was not taken.
integer
C0032976 (UMLS CUI [1,1])
C2826677 (UMLS CUI [1,2])
Lab Status
Code List
Select "Not done" if urine sample was not taken.
CL Item
Not Done (1)
Date of specimen collection
Item
Date of specimen collection
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
result pregnancy test
integer
C3259477 (UMLS CUI [1])
result pregnancy test
Code List
result pregnancy test
CL Item
negative (1)
CL Item
positive (2)
Item Group
Meal Data
C0016452 (UMLS CUI-1)
Date Food Intake
Item
Date Food Intake
date
C0016452 (UMLS CUI [1])
Start time of meal
Item
Time of first food intake
time
C0016452 (UMLS CUI [1])
Item Group
Blood Sample
C0005834 (UMLS CUI-1)
Date of Dose
Item
Date of Dose of ASP1941 on Day of blood sampling
date
C1762893 (UMLS CUI [1])
Time of Last Dose of Study Drug
Item
Time of Last Dose of Study Drug
time
C0946444 (UMLS CUI [1])
Date of Dose
Item
Date of Dose of ASP1941 on day before blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2])
Item
Check if Sample Not Drawn or Not Sent to Lab
integer
C0005834 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Not Done
Code List
Check if Sample Not Drawn or Not Sent to Lab
CL Item
Not Done (1)
Date of Sample
Item
Date of Sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Sample Time
Item
Sample Time
time
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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