date of visit
Item
date of visit
date
C1320303 (UMLS CUI [1])
subject ID
Item
subject ID
text
C2348585 (UMLS CUI [1])
Item
visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
CL Item
Screening Visit (1)
CL Item
Follow-Up Visit (2)
dosing date and time
Item
dosing date and time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
date of ECG
Item
date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
time relative to dosing
text
C0439564 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Code List
time relative to dosing
CL Item
pre-dose 1 of 3 (1)
CL Item
pre-dose 2 of 3 (2)
CL Item
pre-dose 3 of 3 (3)
time of ECG
Item
time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
ECG: heart rate
Item
ECG: heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
ECG: PR interval
Item
ECG: PR interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
ECG: QRS duration
Item
ECG: QRS duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
ECG: uncorrected QT-interval
Item
ECG: uncorrected QT-interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
ECG: QTc interval
Item
ECG: QTc interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
result of the ECG
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
result of the ECG
CL Item
Abnormal - not clinically significant (2)
CL Item
abnormal, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE) (3)
CL Item
no result (not available) (4)