Administrative documentation
Beskrivning

Administrative documentation

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

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

12-Lead ECG

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

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

Datatyp

datetime

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

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

Datatyp

integer

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

Ventricular Rate

Datatyp

float

Måttenheter
  • Beats/min
Alias
UMLS CUI [1]
C2189285
Beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C4072785
UMLS CUI [1,2]
C0429028
msec
QTc Interval
Beskrivning

QTc Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG Result
Beskrivning

ECG Result

Datatyp

integer

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

Predose 24 hour Telemetry ECG

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

Start date and time of ECG

Datatyp

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
Beskrivning

End date and time ECG

Datatyp

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
Beskrivning

Result of the ECG

Datatyp

integer

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

Postdose 24 Hour Telemetry ECG

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

Start Date and time of ECG

Datatyp

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
Beskrivning

End Date and time of ECG

Datatyp

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
Beskrivning

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.

Datatyp

integer

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

10 Hour Telemetry ECG

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

Start Date and Time of the ECG

Datatyp

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
Beskrivning

End Date and Time of the ECG

Datatyp

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
Beskrivning

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.

Datatyp

integer

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

Similar models

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)