Date of visit/ assessment
Item
Date of visit/ assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Assessment Time
Item
Assessment Time
date
C1516048 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Sample taken - not done
integer
C0200345 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Code List
Sample taken - not done
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
Item
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
boolean
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
Item
Specify type of liver chemistry event
integer
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Code List
Specify type of liver chemistry event
CL Item
Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria) (1)
CL Item
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria or has been monitored for 4 weeks and continues to meet liver chemistry event criteria) (3)
Sample taken?
Item
Sample taken?
boolean
C0201734 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
Start date and Actual start time
Item
Start date and Actual start time
datetime
C3897500 (UMLS CUI [1])
Investigational product (Last Dose) date/time
Item
Investigational product (Last Dose) date/time
datetime
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1762893 (UMLS CUI [2,2])
Investigational product (2nd Last Dose) date/time
Item
Investigational product (2nd Last Dose) date/time
datetime
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1762893 (UMLS CUI [2,2])
Investigational product (3rd Last Dose) date/time
Item
Investigational product (3rd Last Dose) date/time
datetime
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1762893 (UMLS CUI [2,2])
PK Type Code
Item
PK Type Code
text
C0031328 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTcB (Bazett)
Item
QTcB (Bazett)
integer
C1882512 (UMLS CUI [1])
QTcF (Fridericia)
Item
QTcF (Fridericia)
integer
C1882513 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item
If abnormal ECG, specify
text
C0522055 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
If abnormal ECG, specify
CL Item
Sinus bradycardia ([A1])
CL Item
Sinus tachycardia (heart rate > 100 beats/min) ([A2])
CL Item
Atrial fibrillation ([A8])
CL Item
Right bundle branch block ([C8])
CL Item
Left bundle branch block ([C9])
CL Item
Myocardial infarction, old ([D1])
CL Item
Enter comment ([E99])