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])
Waist circumference
Item
Waist circumference
float
C0455829 (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])
Item
What is your assessment of the subject's investigational product compliance (in % ) since the last visit?
integer
C0304229 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Code List
What is your assessment of the subject's investigational product compliance (in % ) since the last visit?
CL Item
0% compliant (subject did not take any doses) (1)
CL Item
> 0% and < 80% compliant (subject missed a number of doses) (2)
CL Item
>=80% and <=120% (number of doses taken was within compliance range) (3)
CL Item
> 120% compliant (number of doses taken exceeds compliance limits) (4)
Item
I f compliance is < 80% or > 120% , check the box next to any reason(s) below that apply.
integer
C0304229 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
I f compliance is < 80% or > 120% , check the box next to any reason(s) below that apply.
CL Item
Adverse event (ensure that details are recorded in the Adverse Events panel) (1)
CL Item
Dispensing error (2)
CL Item
Subject did not take medication according to protocol (3)
Investigational Product Compliance Reason
Item
If other reason, please specify
text
C0304229 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
subject continuing
Item
Is the subject continuing in the study?
boolean
C0805733 (UMLS CUI [1])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])