Informações:
Falhas:
ID
16917
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 MellitusTEST Study Visit 7, Visit 8
Palavras-chave
Versões (1)
- 14/08/2016 14/08/2016 -
Transferido a
14 de agosto de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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DM-ASP1941-1941-CL-0004 NCT01071850
Visit 7, Visit 8 DM-ASP1941-1941-CL-0004 NCT01071850
- StudyEvent: ODM
Similar models
Visit 7, Visit 8 DM-ASP1941-1941-CL-0004 NCT01071850
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
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 (Sitting)
CL Item
Standing (Standing)
Item
Location of blood pressure measurement
integer
C0005823 (UMLS CUI [1])
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])
Item
ECG Interpretation
integer
C1623258 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])
C0459471 (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
C2985720 (UMLS CUI [1])
Weight
Item
Weight
text
C0005910 (UMLS CUI [1])
Item Group
Waist and Hip Circumference
C0455829 (UMLS CUI-1)
C0562350 (UMLS CUI-3)
C0562350 (UMLS CUI-3)
Waist Circumference
Item
Waist Circumference
text
C0455829 (UMLS CUI [1])
Hip Circumference
Item
Hip Circumference
text
C0562350 (UMLS CUI [1])
Item
Select "Not done" if urine sample was not taken.
integer
C0032976 (UMLS CUI [1,1])
C2826677 (UMLS CUI [1,2])
C2826677 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
CL Item
negative (1)
CL Item
positive (2)
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])
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])
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])
C1272696 (UMLS CUI [1,2])
CL Item
Not Done (1)
Date of Sample
Item
Date of Sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Sample Time
Item
Sample Time
time
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])