ID

17684

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 Mellitus Unscheduled Visit

Keywords

Versions (2)
  1. 9/5/16 9/5/16 -
  2. 9/28/16 9/28/16 -
Uploaded on

September 28, 2016

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Unscheduled Visit Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

English

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

1 forms  
Unscheduled Visit Checklist
Description

Unscheduled Visit Checklist

Alias
UMLS CUI-1
C1548404
Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Physical Examination?
Description

Physical Examination

Data type

boolean

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

Orthostatic Vital Signs

Data type

boolean

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

ECG: 12 Lead ECG 1

Data type

boolean

Alias
UMLS CUI [1]
C0013798
Weight?
Description

Weight

Data type

boolean

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

Study drug Accountability

Data type

boolean

Alias
UMLS CUI [1]
C2981453
Physical Examination
Description

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.
Description

Physical Examination

Data type

boolean

Alias
UMLS CUI [1]
C0031809
Assessment Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C2985720
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
Position
Description

Vital Signs

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

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Description

Pulse Rate

Data type

text

Measurement units
  • Beats/min
Alias
UMLS CUI [1]
C0232117
Beats/min
12 Lead ECG 1
Description

12 Lead ECG 1

Alias
UMLS CUI-1
C0013798
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

text

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 [1,1]
C0005910
UMLS CUI [1,2]
C2985720
Body weight
Description

Weight

Data type

text

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Study Drug: Accountability - Unscheduled
Description

Study Drug: Accountability - Unscheduled

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

Dispensed Date

Data type

date

Alias
UMLS CUI [1]
C3173309
Replacement Kit Number
Description

Replacement Kit Number

Data type

text

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

Amount dispensed

Data type

text

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

Any Containers Returned

Data type

boolean

Alias
UMLS CUI [1]
C0180098
Returned Date
Description

Returned Date

Data type

date

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

Amount Returned

Data type

text

Alias
UMLS CUI [1]
C2699071
Comment
Description

Comment

Data type

text

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

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Vital Signs
Code List
Position
CL Item
Sitting  (1)
CL Item
Standing (2)
Item
integer
C0005823 (UMLS CUI [1])
Location of blood pressure measurement
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])
ECG Interpretation
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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