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This is the SDTM data associated with the CRF above.

Yes;No

Dataset wrap

Name	eg

Rowcaps

Row 1:	Shows a measurement of ventricular rate.
Row 2:	Shows a measurement of PR interval.
Rows 3-4:	These interval measurements were collected in seconds. However, in this submission, the standard unit for these tests was milliseconds, so the results have been converted in EGSTRESC and EGSTRESN.
Row 5:	Shows "QTcB Interval, Aggregate". This result was derived by the applicant, as indicated by the “Y” in the EGDRVFL column. Note that EGORRES is null for these derived records.
Row 6:	Shows the result of the TEST "Interpretation" (i.e., the interpretation of the ECG strip as a whole), which for this ECG was "ABNORMAL". This result was assessed as clinically significant (EGCLSIG = "Y").

Dataset2

Row	STUDYID	DOMAIN	USUBJID	EGSEQ	EGREFID	EGTESTCD	EGTEST	EGCAT	EGPOS	EGORRES	EGORRESU	EGSTRESC	EGSTRESN	EGSTRESU	EGNAM	EGMETHOD	EGDRVFL	EGCLSIG	VISITNUM	VISIT	EGDTC	EGDY
1	XYZ	EG	XYZ-US-701-002	1	334PT89	EGHRMN	ECG Mean Heart Rate	MEASUREMENT	SUPINE	62	beats/min	62	62	beats/min	Test Lab	12 LEAD STANDARD			1	SCREENING	2003-04-15T11:58	-36
2	XYZ	EG	XYZ-US-701-002	2	334PT89	PRAG	PR Interval, Aggregate	INTERVAL	SUPINE	0.15	sec	150	150	msec	Test Lab	12 LEAD STANDARD			1	SCREENING	2003-04-15T11:58	-36
3	XYZ	EG	XYZ-US-701-002	3	334PT89	QRSAG	QRS Duration, Aggregate	INTERVAL	SUPINE	0.103	sec	103	103	msec	Test Lab	12 LEAD STANDARD			1	SCREENING	2003-04-15T11:58	-36
4	XYZ	EG	XYZ-US-701-002	4	334PT89	QTAG	QT Interval, Aggregate	INTERVAL	SUPINE	0.406	sec	406	406	msec	Test Lab	12 LEAD STANDARD			1	SCREENING	2003-04-15T11:58	-36
5	XYZ	EG	XYZ-US-701-002	5	334PT89	QTCA	QTcA Interval, Aggregate	INTERVAL	SUPINE			469	469	msec	Test Lab	12 LEAD STANDARD	Y		1	SCREENING	2003-04-15T11:58	-36
6	XYZ	EG	XYZ-US-701-002	12	334PT89	INTP	Interpretation		SUPINE	ABNORMAL		ABNORMAL						Y	1	SCREENING	2003-04-15T11:58	-36

Xformpusher

CDASH Variable

Order

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTM Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-Populated Value

Query Display

List Style

Hidden

EGPERF

1

Was the ECG performed?

ECG Performed

Indicate whether or not an ECG or specific ECG test was done.

Text

EGSTAT

(NY)

Yes; No

EGMETHOD

2

What was the method used for the ECG?

Method

Record the method used for the ECG.

Text

EGMETHOD

(EGMETHOD)

6 Lead Standard; 8 Lead Standard; 10 Lead Standard; 12 Lead Standard

EGPOS

3

What was the position of the subject during the ECG measurement?

Position

Record the position of the subject during the ECG.

Text

EGPOS

(POSITION)

Supine; Sitting

EGDAT

4

What was date of the ECG?

ECG Date

Record the date ECG was done using this format (DD-MON-YYYY).

Date

EGDTC

EGTPT

5

What was the planned time point of the ECG measurement?

[Planned Time Point Name]

Record the time point labels for when the ECG test should be taken, if not pre-printed on the CRF.

Text

EGTPT

EGTIM

6

What was the time the ECG was collected?

ECG Time

Record the time the ECG was done (as complete as possible).

Time

EGDTC

PRAG_EGORRES

7

What was the Aggregate PR Interval?

PR Interval, Aggregate

Record the test result.

Text

EGORRES

EGORRES where EGTESTCD = "PRAG"

PRAG_EGORRESU

8

What was the unit of the Aggregate PR Interval?

Unit

Record or select the original unit in which these data were collected, if not pre-printed on CRF.

Text

EGORRES

EGORRESU where EGTESTCD = "PRAG"

(Unit)

msecs

QRSAG_EGORRES

9

What was the Aggregate QRS Duration?

QRS Duration, Aggregate

Record the test result.

Text

EGORRES

EGORRES where EGTESTCD = "QRSAG"

QRSAG_EGORRESU

10

What was the unit of the Aggregate QRS Duration?

Unit

Record or select the original unit in which these data were collected, if not pre-printed on CRF.

Text

EGORRES

EGORRESU where EGTESTCD = "QRSAG"

(Unit)

msecs

QTAG_EGORRES

11

What was the Aggregate QT Interval?

QT Interval, Aggregate

Record the test result.

Text

EGORRES

EGORRES where EGTESTCD = "QTAG"

QTAG_EGORRESU

12

What was the unit of the Aggregate QT Interval result?

Unit

Record or select the original unit in which these data were collected, if not pre-printed on CRF.

Text

EGORRES

EGORRESU where EGTESTCD = "QTAG"

(Unit)

msecs

QTCAAG_EGORRES

13

What was the Aggregate QTca Interval?

QTca Interval, Aggregate

Record the test result.

Text

EGORRES

EGORRES where EGTESTCD = "QTCAAG"

QTCAAG_EGORRESU

14

What was the unit of the Aggregate QTca Interval?

Unit

Record or select the original unit in which these data were collected, if not pre-printed on CRF.

Text

EGORRES

EGORRESU where EGTESTCD = "QTCAAG"

(Unit)

msecs

INTP_EGORRES

15

What was the overall interpretation of the ECG?

Interpretation

Record the the test result.

Text

EGORRES

EGORRES where EGTESTCD = "INTP"

(NORMABNM)

Normal; Abnormal

EGCLSIG

16

Was the ECG clinically significant?

Clinically Significant

Record whether ECG results were clinically significant.

Text

SUPPEG.QVAL

SUPPEG.QVAL where SUPPEG.QNAM = "EGCLSIG" and SUPPEG.QLABEL= "Clinically Significant" and EGTESTCD= "INTP"

(NY)

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