ID

44881

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 MellitusTEST Study Visit 3

Keywords

  1. 8/10/16 8/10/16 -
  2. 9/28/16 9/28/16 -
  3. 9/28/16 9/28/16 -
  4. 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 3 (Washout) Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

Visit 3 (Washout) Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

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]
C0005823
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]
C0430456
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

Similar models

Visit 3 (Washout) Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

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])
Code List
Vital Signs
CL Item
Sitting (Sitting)
CL Item
Standing (Standing)
Item
Location of blood pressure measurement
integer
C0005823 (UMLS CUI [1])
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
C0430456 (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])
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])

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