ID

17679

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 Dosing

Keywords

Versions (2)
  1. 8/15/16 8/15/16 -
  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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Dosing Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

English

Dosing Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

1 forms  
Study Drug: oral
Description

Study Drug: oral

Alias
UMLS CUI-1
C0013175
Type of Study Drug
Description

Type of Study Drug

Data type

integer

Alias
UMLS CUI [1]
C0457591
Study Treatment Status Not Done
Description

Not Done

Data type

integer

Alias
UMLS CUI [1]
C1272696
UMLS CUI [2]
C0678766
date of first dose
Description

first dose date

Data type

date

Alias
UMLS CUI [1]
C3173309
Date of last dose
Description

Date of last dose

Data type

date

Alias
UMLS CUI [1]
C1762893
Study Drug: Accountability - Kit 1
Description

Study Drug: Accountability - Kit 1

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

Dispensed Date

Data type

date

Alias
UMLS CUI [1]
C3173309
Kit Number assigned
Description

Kit Number assigned

Data type

text

Alias
UMLS CUI [1]
C2981406
Actual Kit Number
Description

Actual Kit Number

Data type

text

Alias
UMLS CUI [1]
C2981406
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
Study Drug: Accountability - Kit 2
Description

Study Drug: Accountability - Kit 2

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

Dispensed Date

Data type

date

Alias
UMLS CUI [1]
C3173309
Kit Number assigned
Description

Kit Number assigned

Data type

text

Alias
UMLS CUI [1]
C2981406
Actual Kit Number
Description

Actual Kit Number

Data type

text

Alias
UMLS CUI [1]
C2981406
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
Study Drug: Accountability - Kit 3
Description

Study Drug: Accountability - Kit 3

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

Dispensed Date

Data type

date

Alias
UMLS CUI [1]
C3173309
Kit Number assigned
Description

Kit Number assigned

Data type

text

Alias
UMLS CUI [1]
C2981406
Actual Kit Number
Description

Actual Kit Number

Data type

text

Alias
UMLS CUI [1]
C2981406
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
Study Drug: Accountability - Kit 4
Description

Study Drug: Accountability - Kit 4

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

Dispensed Date

Data type

date

Alias
UMLS CUI [1]
C3173309
Kit Number assigned
Description

Kit Number assigned

Data type

text

Alias
UMLS CUI [1]
C2981406
Actual Kit Number
Description

Actual Kit Number

Data type

text

Alias
UMLS CUI [1]
C2981406
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

Dosing Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Drug: oral
C0013175 (UMLS CUI-1)
Item
Type of Study Drug
integer
C0457591 (UMLS CUI [1])
Type of Study Drug
Code List
Type of Study Drug
CL Item
Run-In Medication (1)
CL Item
Randomized Study Drug (2)
Not Done
Item
Study Treatment Status Not Done
integer
C1272696 (UMLS CUI [1])
C0678766 (UMLS CUI [2])
first dose date
Item
date of first dose
date
C3173309 (UMLS CUI [1])
Date of last dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
Item Group
Study Drug: Accountability - Kit 1
C0013175 (UMLS CUI-1)
C0078889 (UMLS CUI-2)
Dispensed Date
Item
Dispensed Date
date
C3173309 (UMLS CUI [1])
Kit Number assigned
Item
Kit Number assigned
text
C2981406 (UMLS CUI [1])
Actual Kit Number
Item
Actual Kit Number
text
C2981406 (UMLS CUI [1])
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])
Item Group
Study Drug: Accountability - Kit 2
C0013175 (UMLS CUI-1)
C0078889 (UMLS CUI-2)
Dispensed Date
Item
Dispensed Date
date
C3173309 (UMLS CUI [1])
Kit Number assigned
Item
Kit Number assigned
text
C2981406 (UMLS CUI [1])
Actual Kit Number
Item
Actual Kit Number
text
C2981406 (UMLS CUI [1])
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])
Item Group
Study Drug: Accountability - Kit 3
C0013175 (UMLS CUI-1)
C0078889 (UMLS CUI-2)
Dispensed Date
Item
Dispensed Date
date
C3173309 (UMLS CUI [1])
Kit Number assigned
Item
Kit Number assigned
text
C2981406 (UMLS CUI [1])
Actual Kit Number
Item
Actual Kit Number
text
C2981406 (UMLS CUI [1])
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])
Item Group
Study Drug: Accountability - Kit 4
C0013175 (UMLS CUI-1)
C0078889 (UMLS CUI-2)
Dispensed Date
Item
Dispensed Date
date
C3173309 (UMLS CUI [1])
Kit Number assigned
Item
Kit Number assigned
text
C2981406 (UMLS CUI [1])
Actual Kit Number
Item
Actual Kit Number
text
C2981406 (UMLS CUI [1])
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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