ID

17293

Descripción

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 Unscheduled Visit

Palabras clave

  1. 5/9/16 5/9/16 -
  2. 28/9/16 28/9/16 -
Subido en

5 de septiembre de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy

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DM-ASP1941-1941-CL-0004 NCT01071850

Unscheduled Visit DM-ASP1941-1941-CL-0004 NCT01071850

Unscheduled Visit Checklist
Descripción

Unscheduled Visit Checklist

Alias
UMLS CUI-1
C1548404
Date
Descripción

Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Physical Examination?
Descripción

Physical Examination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031809
Orthostatic Vital Signs?
Descripción

Orthostatic Vital Signs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518766
ECG: 12 Lead ECG 1?
Descripción

ECG: 12 Lead ECG 1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013798
Weight?
Descripción

Weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005910
Study drug Accountability?
Descripción

Study drug Accountability

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2981453
Physical Examination
Descripción

Physical Examination

Alias
UMLS CUI-1
C0031809
Was the physical examination performed? Record any abnormal findings/conditions identified during the exam on the appropriate form.
Descripción

Physical Examination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031809
Assessment Date
Descripción

Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C2985720
Orthostatic vital signs
Descripción

Orthostatic vital signs

Alias
UMLS CUI-1
C0518766
Not Done:
Descripción

Assessment

Tipo de datos

boolean

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

Assessment Date

Tipo de datos

date

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

Assessment Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0040223
Position
Descripción

Vital Signs

Tipo de datos

integer

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

Location of blood pressure measurement

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005823
Systolic blood pressure
Descripción

Systolic blood pressure

Tipo de datos

text

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

text

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Descripción

Pulse Rate

Tipo de datos

text

Unidades de medida
  • Beats/min
Alias
UMLS CUI [1]
C0232117
Beats/min
12 Lead ECG 1
Descripción

12 Lead ECG 1

Alias
UMLS CUI-1
C0013798
Date ECG was performed
Descripción

ECG Date

Tipo de datos

date

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

ECG time

Tipo de datos

time

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

ECG Interpretation

Tipo de datos

text

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

Weight

Alias
UMLS CUI-1
C0005910
Assessment Date
Descripción

Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C2985720
Body weight
Descripción

Weight

Tipo de datos

text

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Study Drug: Accountability - Unscheduled
Descripción

Study Drug: Accountability - Unscheduled

Alias
UMLS CUI-1
C0013175
UMLS CUI-2
C0078889
Dispensed Date
Descripción

Dispensed Date

Tipo de datos

date

Alias
UMLS CUI [1]
C3173309
Replacement Kit Number
Descripción

Replacement Kit Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2981406
UMLS CUI [1,2]
C0559956
No. of capsules dispensed
Descripción

Amount dispensed

Tipo de datos

text

Alias
UMLS CUI [1]
C0805077
Were any of the wallets within the kit returned?
Descripción

Any Containers Returned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0180098
Returned Date
Descripción

Returned Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0180098
UMLS CUI [1,2]
C1547350
No. of Capsules / Tablets returned
Descripción

Amount Returned

Tipo de datos

text

Alias
UMLS CUI [1]
C2699071
Comment
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0078889
UMLS CUI [1,2]
C0947611

Similar models

Unscheduled Visit DM-ASP1941-1941-CL-0004 NCT01071850

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Unscheduled Visit Checklist
C1548404 (UMLS CUI-1)
Assessment Date
Item
Date
date
C2985720 (UMLS CUI [1])
Physical Examination
Item
Physical Examination?
boolean
C0031809 (UMLS CUI [1])
Orthostatic Vital Signs
Item
Orthostatic Vital Signs?
boolean
C0518766 (UMLS CUI [1])
ECG: 12 Lead ECG 1
Item
ECG: 12 Lead ECG 1?
boolean
C0013798 (UMLS CUI [1])
Weight
Item
Weight?
boolean
C0005910 (UMLS CUI [1])
Study drug Accountability
Item
Study drug Accountability?
boolean
C2981453 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination
Item
Was the physical examination performed? Record any abnormal findings/conditions identified during the exam on the appropriate form.
boolean
C0031809 (UMLS CUI [1])
Assessment Date
Item
Assessment Date
date
C0031809 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
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
Position
integer
C0518766 (UMLS CUI [1])
Code List
Position
CL Item
Sitting  (1)
CL Item
Standing (2)
Item
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
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
text
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
C0005910 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Weight
Item
Body weight
text
C0005910 (UMLS CUI [1])
Item Group
Study Drug: Accountability - Unscheduled
C0013175 (UMLS CUI-1)
C0078889 (UMLS CUI-2)
Dispensed Date
Item
Dispensed Date
date
C3173309 (UMLS CUI [1])
Replacement Kit Number
Item
Replacement Kit Number
text
C2981406 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
Amount dispensed
Item
No. of capsules dispensed
text
C0805077 (UMLS CUI [1])
Any Containers Returned
Item
Were any of the wallets within the kit returned?
boolean
C0180098 (UMLS CUI [1])
Returned Date
Item
Returned Date
date
C0180098 (UMLS CUI [1,1])
C1547350 (UMLS CUI [1,2])
Amount Returned
Item
No. of Capsules / Tablets returned
text
C2699071 (UMLS CUI [1])
Comment
Item
Comment
text
C0078889 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])

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