ID

44876

Description

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 Mellitus Visit 8

Keywords

Versions (2)
  1. 9/28/16 9/28/16 -
  2. 2/19/22 2/19/22 - Martin Dugas
Copyright Holder

Astellas Pharma Inc

Uploaded on

February 19, 2022

DOI

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License

Creative Commons BY-NC 4.0
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Visit 8 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

English

Visit 8 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

1 forms  
Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit
Description

Visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Orthostatic Vital Signs
Description

Orthostatic Vital Signs

Alias
UMLS CUI-1
C0518766
Not done:
Description

Assessment

Data type

boolean

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

Assessment Date

Data type

date

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

Assessment Time

Data type

time

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

Position

Data type

integer

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

Location of blood pressure measurement

Data type

integer

Alias
UMLS CUI [1]
C1651662
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Description

Pulse Rate

Data type

integer

Measurement units
  • Beats/min
Alias
UMLS CUI [1]
C0232117
Beats/min
ECG: 12 Lead ECG 1
Description

ECG: 12 Lead ECG 1

Alias
UMLS CUI-1
C0013798
Date ECG was performed
Description

ECG Date

Data type

date

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

ECG time

Data type

time

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

ECG Interpretation

Data type

integer

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

Weight

Alias
UMLS CUI-1
C0005910
Assessment Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Waist and Hip Circumference
Description

Waist and Hip Circumference

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

Waist Circumference

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0455829
cm
Hip Circumference
Description

Hip Circumference

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0562350
cm
Pregnancy Test
Description

Pregnancy Test

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

Lab Status

Data type

integer

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

Date of specimen collection

Data type

date

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

result pregnancy test

Data type

integer

Alias
UMLS CUI [1]
C0427777
Meal Data
Description

Meal Data

Alias
UMLS CUI-1
C0016452
Date Food Intake
Description

Date Food Intake

Data type

date

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

Start time of meal

Data type

time

Alias
UMLS CUI [1]
C0016452
Blood Sample
Description

Blood Sample

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

Date of Dose

Data type

date

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

Time of Last Dose of Study Drug

Data type

time

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

Date of Dose

Data type

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
Description

Not Done

Data type

integer

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

Date of Sample

Data type

date

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

Sample Time

Data type

time

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

Visit 8 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
C1651662 (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
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse Rate
integer
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
float
C0005910 (UMLS CUI [1])
Item Group
Waist and Hip Circumference
C0455829 (UMLS CUI-1)
C0562350 (UMLS CUI-3)
Waist Circumference
Item
Waist Circumference
float
C0455829 (UMLS CUI [1])
Hip Circumference
Item
Hip Circumference
float
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
C0427777 (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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