ID

16917

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 7, Visit 8

Mots-clés

  1. 14/08/2016 14/08/2016 -
Téléchargé le

14 août 2016

DOI

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Licence

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
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit
Description

Visit date

Type de données

date

Alias
UMLS CUI [1]
C1320303
Orthostatic Vital Signs
Description

Orthostatic Vital Signs

Alias
UMLS CUI-1
C0518766
Not done:
Description

Assessment

Type de données

boolean

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

Assessment Date

Type de données

date

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

Assessment Time

Type de données

time

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

Position

Type de données

integer

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

Location of blood pressure measurement

Type de données

integer

Alias
UMLS CUI [1]
C0005823
Systolic Blood Pressure
Description

Systolic Blood Pressure

Type de données

text

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Type de données

text

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Description

Pulse Rate

Type de données

text

Unités de mesure
  • 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

Type de données

date

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

ECG time

Type de données

time

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

ECG Interpretation

Type de données

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

Type de données

date

Alias
UMLS CUI [1]
C2985720
Weight
Description

Weight

Type de données

text

Unités de mesure
  • 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

Type de données

text

Unités de mesure
  • cm
Alias
UMLS CUI [1]
C0455829
cm
Hip Circumference
Description

Hip Circumference

Type de données

text

Unités de mesure
  • 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

Type de données

integer

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

Date of specimen collection

Type de données

date

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

result pregnancy test

Type de données

integer

Alias
UMLS CUI [1]
C3259477
Meal Data
Description

Meal Data

Alias
UMLS CUI-1
C0016452
Date Food Intake
Description

Date Food Intake

Type de données

date

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

Start time of meal

Type de données

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

Type de données

date

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

Time of Last Dose of Study Drug

Type de données

time

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

Date of Dose

Type de données

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

Type de données

integer

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

Date of Sample

Type de données

date

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

Sample Time

Type de données

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
Type
Description | Question | Decode (Coded Value)
Type de données
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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