Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
adverse events
Item
Are there any new adverse events/ serious adverse events observed or reported by the subject or any changes to ongoing adverse events?
boolean
C0877248 (UMLS CUI [1])
changes concomitant medication
Item
Has there been any changes to the subject's concomitant medication or any new medications taken since the last visit?
boolean
C2347852 (UMLS CUI [1,1])
C2169461 (UMLS CUI [1,2])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Blood Pressure - sitting, Systolic
Item
Blood Pressure - sitting, Systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Blood Pressure - sitting, Diastolic
Item
Blood Pressure - sitting, Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
lab samples
Item
Were lab samples obtained?
boolean
C0005834 (UMLS CUI [1])
C0200354 (UMLS CUI [2])
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Inclusion Criteria
Item
Did the subject meet all of the inclusion criteria at Visit 3?
boolean
C1512693 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
Item
inclusion criteria the subject failed
integer
C1512693 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Code List
inclusion criteria the subject failed
CL Item
Subjects with FPG < = 270 mg/ dL (15mmol/ L) at Visit 3 (week -4). (1)
exception(s) Inclusion Criteria
Item
Please clarify the exception(s) below:
text
C1705847 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,3])
subject continuing
Item
Is the subject continuing in the study?
boolean
C0805733 (UMLS CUI [1])