ID

16917

Beskrivning

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

Nyckelord

  1. 2016-08-14 2016-08-14 -
Uppladdad den

14 augusti 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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DM-ASP1941-1941-CL-0004 NCT01071850

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

Date of Visit
Beskrivning

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit
Beskrivning

Visit date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Orthostatic Vital Signs
Beskrivning

Orthostatic Vital Signs

Alias
UMLS CUI-1
C0518766
Not done:
Beskrivning

Assessment

Datatyp

boolean

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

Assessment Date

Datatyp

date

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

Assessment Time

Datatyp

time

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

Position

Datatyp

integer

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

Location of blood pressure measurement

Datatyp

integer

Alias
UMLS CUI [1]
C0005823
Systolic Blood Pressure
Beskrivning

Systolic Blood Pressure

Datatyp

text

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

text

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Beskrivning

Pulse Rate

Datatyp

text

Måttenheter
  • Beats/min
Alias
UMLS CUI [1]
C0232117
Beats/min
ECG: 12 Lead ECG 1
Beskrivning

ECG: 12 Lead ECG 1

Alias
UMLS CUI-1
C0013798
Date ECG was performed
Beskrivning

ECG Date

Datatyp

date

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

ECG time

Datatyp

time

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

ECG Interpretation

Datatyp

integer

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

Weight

Alias
UMLS CUI-1
C0005910
Assessment Date
Beskrivning

Assessment Date

Datatyp

date

Alias
UMLS CUI [1]
C2985720
Weight
Beskrivning

Weight

Datatyp

text

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Waist and Hip Circumference
Beskrivning

Waist and Hip Circumference

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

Waist Circumference

Datatyp

text

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0455829
cm
Hip Circumference
Beskrivning

Hip Circumference

Datatyp

text

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0562350
cm
Pregnancy Test
Beskrivning

Pregnancy Test

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

Lab Status

Datatyp

integer

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

Date of specimen collection

Datatyp

date

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

result pregnancy test

Datatyp

integer

Alias
UMLS CUI [1]
C3259477
Meal Data
Beskrivning

Meal Data

Alias
UMLS CUI-1
C0016452
Date Food Intake
Beskrivning

Date Food Intake

Datatyp

date

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

Start time of meal

Datatyp

time

Alias
UMLS CUI [1]
C0016452
Blood Sample
Beskrivning

Blood Sample

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

Date of Dose

Datatyp

date

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

Time of Last Dose of Study Drug

Datatyp

time

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

Date of Dose

Datatyp

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
Beskrivning

Not Done

Datatyp

integer

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

Date of Sample

Datatyp

date

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

Sample Time

Datatyp

time

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

Similar models

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

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
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])
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])
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])
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])
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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