ID

44876

Beschreibung

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

Stichworte

  1. 28.09.16 28.09.16 -
  2. 19.02.22 19.02.22 - Martin Dugas
Rechteinhaber

Astellas Pharma Inc

Hochgeladen am

19. Februar 2022

DOI

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Lizenz

Creative Commons BY-NC 4.0

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

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

Date of Visit
Beschreibung

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit
Beschreibung

Visit date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Orthostatic Vital Signs
Beschreibung

Orthostatic Vital Signs

Alias
UMLS CUI-1
C0518766
Not done:
Beschreibung

Assessment

Datentyp

boolean

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

Assessment Date

Datentyp

date

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

Assessment Time

Datentyp

time

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

Position

Datentyp

integer

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

Location of blood pressure measurement

Datentyp

integer

Alias
UMLS CUI [1]
C1651662
Systolic Blood Pressure
Beschreibung

Systolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Beschreibung

Pulse Rate

Datentyp

integer

Maßeinheiten
  • Beats/min
Alias
UMLS CUI [1]
C0232117
Beats/min
ECG: 12 Lead ECG 1
Beschreibung

ECG: 12 Lead ECG 1

Alias
UMLS CUI-1
C0013798
Date ECG was performed
Beschreibung

ECG Date

Datentyp

date

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

ECG time

Datentyp

time

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

ECG Interpretation

Datentyp

integer

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

Weight

Alias
UMLS CUI-1
C0005910
Assessment Date
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Waist and Hip Circumference
Beschreibung

Waist and Hip Circumference

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

Waist Circumference

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0455829
cm
Hip Circumference
Beschreibung

Hip Circumference

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0562350
cm
Pregnancy Test
Beschreibung

Pregnancy Test

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

Lab Status

Datentyp

integer

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

Date of specimen collection

Datentyp

date

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

result pregnancy test

Datentyp

integer

Alias
UMLS CUI [1]
C0427777
Meal Data
Beschreibung

Meal Data

Alias
UMLS CUI-1
C0016452
Date Food Intake
Beschreibung

Date Food Intake

Datentyp

date

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

Start time of meal

Datentyp

time

Alias
UMLS CUI [1]
C0016452
Blood Sample
Beschreibung

Blood Sample

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

Date of Dose

Datentyp

date

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

Time of Last Dose of Study Drug

Datentyp

time

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

Date of Dose

Datentyp

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
Beschreibung

Not Done

Datentyp

integer

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

Date of Sample

Datentyp

date

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

Sample Time

Datentyp

time

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

Ähnliche Modelle

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

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
C1651662 (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
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
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])
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])
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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