SDTM Example.Electrocardiogram Assessment

This is the SDTM data associated with the CRF above.

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 sponsor, 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").

eg.xpt

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

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