Item
Study part
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
CL Item
Days 10 (Days 10)
CL Item
Days 14 (Days 14)
Item
Dosage Interval
text
C0178602 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
Code List
Dosage Interval
CL Item
Pre-dose 1 (Pre-dose 1)
CL Item
Pre-dose 2 (Pre-dose 2)
CL Item
Pre-dose 3 (Pre-dose 3)
CL Item
0.5 Hours (0.5 Hours)
CL Item
2 Hours (2 Hours)
CL Item
3 Hours (3 Hours)
CL Item
4 Hours (4 Hours)
CL Item
6 Hours (6 Hours)
CL Item
8 Hours (8 Hours)
CL Item
12 Hours (12 Hours)
CL Item
24 Hours (24 Hours)
dosage date and time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT Interval Uncorrected
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine (1)
C0336779 (UMLS CUI-1)
(Comment:en)
CL Item
Manual (2)
C0175674 (UMLS CUI-1)
(Comment:en)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal - not clinically significant (2)
C0205161 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
C1518422 (UMLS CUI-3)
(Comment:en)
CL Item
Abnormal, clinically significant (3)
C0205161 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
(Comment:en)
CL Item
No result (not available) (4)
C1706613 (UMLS CUI-1)
(Comment:en)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C3897500 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Stop Date and Time of ECG
Item
Stop Date and Time of ECG
datetime
C3899266 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal - not clinically significant (2)
C0205161 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
C1518422 (UMLS CUI-3)
(Comment:en)
CL Item
Abnormal, clinically significant (3)
C0205161 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
(Comment:en)
CL Item
No result (not available) (4)
C1706613 (UMLS CUI-1)
(Comment:en)
Item
Study part
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
CL Item
Days 10 (Days 10)
CL Item
Days 14 (Days 14)
start date and time
Item
Start date/time
datetime
C3897500 (UMLS CUI [1])
stop date and time
Item
Stop date/time
datetime
C0806020 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Result of the Holter
integer
C1274040 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
Code List
Result of the Holter
CL Item
Normal (1)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal - not clinically significant (2)
C0205161 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
C1518422 (UMLS CUI-3)
(Comment:en)
CL Item
Abnormal, clinically significant (3)
C0205161 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
(Comment:en)
CL Item
No result (not available) (4)
C1706613 (UMLS CUI-1)
(Comment:en)