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12-Lead ECG treatment period 1-4.

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Treatment period and day
Description

Treatment period and day

Data type

integer

Alias
UMLS CUI [1]
C0087111
12-LEAD ECG
Description

12-LEAD ECG

Alias
UMLS CUI-1
C0430456
Planned relative time
Description

For TP1D1, TP2D1, TP3D1 and TP4D1 tick each 1 and 2. Please take for each three measurements. For TP1D7, TP2D7, TP3D7 and TP4D7 tick each 1-5. Please take for pre-dose each time three measurements.

Data type

integer

Alias
UMLS CUI [1]
C0439564
Date of ECG
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Heart rate ECG
Description

Heart rate ECG

Data type

integer

Measurement units
  • beats / min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C1623258
beats / min
PR Interval
Description

PR Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Description

QRS Duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C4072785
msec
QTcF Calculation
Description

QTcF Calculation

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
msec
Method or QTc Calculatlon
Description

Method or QTc Calculatlon

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Machine record: QTcB (Bazett)
Description

Machine record: QTcB (Bazett)

Data type

boolean

Alias
UMLS CUI [1]
C1882512
If you tick in "Method QTc Calculation Machine record" Machine record, please note QTcB (Bazett)
Description

Machine record: QTcB (Bazett)

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1882512
msec
Machine record: QTc Interval, unspecified method of correction
Description

Machine record: QTc Interval, unspecified method of correction

Data type

boolean

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0205370
UMLS CUI [1,3]
C2911685
If you tick in "Method QTc Calculation Machine record" Machine record, please note QTc Interval, unspecified method of correction
Description

Machine record: QTc Interval, unspecified method of correction

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0205370
UMLS CUI [1,3]
C2911685
msec
RR interval
Description

RR interval

Data type

integer

Alias
UMLS CUI [1]
C0489636
If you tick in "Method QTc Calculation Machine record" manual record, please note RR Interval
Description

Manual record: RR Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C0175674
UMLS CUI [1,3]
C0243095
UMLS CUI [2]
C0489636
msec
Result of the ECG
Description

If 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

Data type

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

12-Lead ECG treatment period 1-4.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Treatment period and day
integer
C0087111 (UMLS CUI [1])
Treatment period type
Code List
Treatment period and day
CL Item
TP1D1 (1)
CL Item
TP1D7 (2)
CL Item
TP2D1 (3)
CL Item
TP2D7 (4)
CL Item
TP3D1 (5)
CL Item
TP3D7 (6)
CL Item
TP4D1 (7)
CL Item
TP4D7 (8)
Item Group
12-LEAD ECG
C0430456 (UMLS CUI-1)
Item
Planned relative time
integer
C0439564 (UMLS CUI [1])
Dosing type
Code List
Planned relative time
CL Item
Pre-dose  (1)
CL Item
1 hr post-dose (2)
CL Item
8 hrs post-dose (3)
CL Item
12 hrs post-dose (4)
CL Item
24 hrs post-dose (5)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart rate ECG
Item
Heart rate ECG
integer
C0018810 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
QTcF Calculation
Item
QTcF Calculation
float
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Item
Method or QTc Calculatlon
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method or QTc Galculatlon
Code List
Method or QTc Calculatlon
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR Interval that precedes the measured QT Interval (2)
Machine record: QTcB (Bazett)
Item
Machine record: QTcB (Bazett)
boolean
C1882512 (UMLS CUI [1])
Machine record: QTcB (Bazett)
Item
If you tick in "Method QTc Calculation Machine record" Machine record, please note QTcB (Bazett)
float
C1882512 (UMLS CUI [1])
Machine record: QTc Interval, unspecified method of correction
Item
Machine record: QTc Interval, unspecified method of correction
boolean
C0489625 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
Machine record: QTc Interval, unspecified method of correction
Item
If you tick in "Method QTc Calculation Machine record" Machine record, please note QTc Interval, unspecified method of correction
float
C0489625 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
Item
RR interval
integer
C0489636 (UMLS CUI [1])
RR interval
Code List
RR interval
CL Item
available (1)
CL Item
not available (2)
Manual record: RR Interval
Item
If you tick in "Method QTc Calculation Machine record" manual record, please note RR Interval
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0489636 (UMLS CUI [2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
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