Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Dosing Date and Time
C0430456 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
C0040223 (UMLS CUI-5)
Dosing date/time
Item
Dosing date/time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Predose 1
C0439565 (UMLS CUI-1)
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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Predose 2
C0439565 (UMLS CUI-1)
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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Predose 3
C0439565 (UMLS CUI-1)
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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
1 Hour
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
2 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
3 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
4 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
6 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
8 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
10 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
12 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
16 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
24 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
30 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
36 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
48 Hours
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-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])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
QRS Axis
Item
QRS Axis
integer
C0429012 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C0855331 (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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)