Administrative documentation
Description

Administrative documentation

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start Date of the ECG
Description

ECG1-10; Planned relative time is Predose 1, 2, 3 and 2 hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
Planned relative time
Description

ECG1-10; Planned relative time is Predose 1, 2, 3 and 2 hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr

Data type

integer

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C1277698
Ventricular Rate
Description

Ventricular Rate

Data type

float

Measurement units
  • Beats/min
Alias
UMLS CUI [1]
C2189285
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]
C4072785
UMLS CUI [1,2]
C0429028
msec
QTc Interval
Description

QTc Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG Result
Description

ECG Result

Data type

integer

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1274040
Predose 24 hour Telemetry ECG
Description

Predose 24 hour Telemetry ECG

Alias
UMLS CUI-1
C0439565
UMLS CUI-2
C0039451
UMLS CUI-3
C0013798
Start date and time of ECG
Description

Start date and time of ECG

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C0013798
End date and time ECG
Description

End date and time ECG

Data type

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013798
UMLS CUI [2,1]
C1522314
UMLS CUI [2,2]
C0013798
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1274040
Postdose 24 Hour Telemetry ECG
Description

Postdose 24 Hour Telemetry ECG

Alias
UMLS CUI-1
C0439568
UMLS CUI-2
C0039451
UMLS CUI-3
C0013798
Start Date and time of ECG
Description

Start Date and time of ECG

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C0013798
End Date and time of ECG
Description

End Date and time of ECG

Data type

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013798
UMLS CUI [2,1]
C1522314
UMLS CUI [2,2]
C0013798
Result of the ECG
Description

If abnormal - clinically significant: Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional Telemetry ECG Abnormalities page if clinically significant abnormalities are present.

Data type

integer

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1274040
10 Hour Telemetry ECG
Description

10 Hour Telemetry ECG

Alias
UMLS CUI-1
C0039451
UMLS CUI-2
C0013798
Start Date and Time of the ECG
Description

Start Date and Time of the ECG

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C0013798
End Date and Time of the ECG
Description

End Date and Time of the ECG

Data type

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013798
UMLS CUI [2,1]
C1522314
UMLS CUI [2,2]
C0013798
Result of the ECG
Description

If abnormal - clinically significant: Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional Telemetry ECG Abnormalities page if clinically significant abnormalities are present.

Data type

integer

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1274040

Similar models

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative documentation
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Start Date and Time of the ECG
Item
Start Date of the ECG
datetime
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Item
Planned relative time
integer
C1301732 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1277698 (UMLS CUI [1,3])
Code List
Planned relative time
CL Item
Predose 1 (1)
CL Item
Predose 2 (2)
CL Item
Predose 3 (3)
CL Item
2hr (4)
CL Item
4hr (5)
CL Item
6hr (6)
CL Item
8hr (7)
CL Item
10hr (8)
CL Item
12hr (9)
CL Item
24hr (10)
Ventricular Rate
Item
Ventricular Rate
float
C2189285 (UMLS CUI [1])
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
C4072785 (UMLS CUI [1,1])
C0429028 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1])
Item
ECG Result
integer
C0013798 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
ECG Result
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
Item Group
Predose 24 hour Telemetry ECG
C0439565 (UMLS CUI-1)
C0039451 (UMLS CUI-2)
C0013798 (UMLS CUI-3)
Start date and time of ECG
Item
Start date and time of ECG
datetime
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C0013798 (UMLS CUI [2,2])
End date and time ECG
Item
End date and time ECG
datetime
C0806020 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C0013798 (UMLS CUI [2,2])
Item
Result of the ECG
integer
C0013798 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
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)
Item Group
Postdose 24 Hour Telemetry ECG
C0439568 (UMLS CUI-1)
C0039451 (UMLS CUI-2)
C0013798 (UMLS CUI-3)
Start Date and time of ECG
Item
Start Date and time of ECG
datetime
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C0013798 (UMLS CUI [2,2])
End Date and time of ECG
Item
End Date and time of ECG
datetime
C0806020 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C0013798 (UMLS CUI [2,2])
Item
Result of the ECG
integer
C0013798 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
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)
Item Group
10 Hour Telemetry ECG
C0039451 (UMLS CUI-1)
C0013798 (UMLS CUI-2)
Start Date and Time of the ECG
Item
Start Date and Time of the ECG
datetime
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C0013798 (UMLS CUI [2,2])
End Date and Time of the ECG
Item
End Date and Time of the ECG
datetime
C0806020 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C0013798 (UMLS CUI [2,2])
Item
Result of the ECG
integer
C0013798 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
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)