Informações:
Falhas:
ID
17684
Descrição
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
Palavras-chave
Versões (2)
- 05/09/2016 05/09/2016 -
- 28/09/2016 28/09/2016 -
Transferido a
28 de setembro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0 Legacy
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Unscheduled Visit Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850
Unscheduled Visit Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850
Similar models
Unscheduled Visit Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
C2985720 (UMLS CUI [1,2])
Assessment
Item
Not Done:
boolean
C0518766 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
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])
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])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
CL Item
Sitting (1)
CL Item
Standing (2)
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])
ECG Date
Item
Date ECG was performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
ECG time
Item
ECG Time performed
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
CL Item
Normal (0 )
CL Item
Abnormal - not clinically significant (1 )
CL Item
Abnormal - clinically significant (2 )
Assessment Date
Item
Assessment Date
date
C0005910 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
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)
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])
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])
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])
C0947611 (UMLS CUI [1,2])