Examples for ECG Test Results (EG) Domain Model

The Cardiovascular Test Results (CV), EG, and Respiratory Test Results (RE) domains are very similar in structure. Note that the examples provided in this section represent uses of timing variables, which could apply to any of these domains, regardless of study type or design.

Example

This example contains ECG measurements during a repeat dose study. Results are for a discrete observation period with a target time point (e.g., 1 hour post-dose). The duration of the ECG recording could be based on a defined period of time (e.g., a cardiologist examining a 2-hour recording and selecting a segment of waveforms for analysis) or number of complexes (e.g., after 200 good complexes are recorded). As a result, EGSTINT and EGENINT are not populated, because the specific assessment interval is not planned.

Rows 1-18: ECGs are performed once, 14 days prior to the day 1 dose; and twice on day 23, once immediately prior to dose and once 2 hours post-dose. Measurements that were collected originally in seconds are converted to units of milliseconds for the study.

eg.xpt

Row	STUDYID	DOMAIN	USUBJID	EGSEQ	EGTESTCD	EGTEST	EGPOS	EGORRES	EGORRESU	EGSTRESC	EGSTRESN	EGSTRESU	EGLEAD	EGMETHOD	EGCSTATE	EGBLFL	EGDTC	EGDY	EGNOMDY	EGTPT	EGTPTNUM	EGELTM	EGTPTREF	EGRFTDTC
1	TSA1397	EG	1	1	EGHRMN	ECG Mean Heart Rate	SLING	89	beats/min	89	89	beats/min	LEAD II	6 LEAD STANDARD	CONSCIOUS		2008-10-28T07:46	-14	-14	Pretest	1	-P14D	Day 1 Dose	2008-11-11T08:54
2	TSA1397	EG	1	2	EGHRMN	ECG Mean Heart Rate	SLING	91	beats/min	91	91	beats/min	LEAD II	6 LEAD STANDARD	CONSCIOUS	Y	2008-12-03T09:05	23	23	Predose	2	-PT5M	Day 23 Dose	2008-12-03T09:10
3	TSA1397	EG	1	3	EGHRMN	ECG Mean Heart Rate	SLING	116	beats/min	116	116	beats/min	LEAD II	6 LEAD STANDARD	CONSCIOUS		2008-12-03T11:03	23	23	2 Hour Postdose	3	PT120M	Day 23 Dose	2008-12-03T09:10
4	TSA1397	EG	1	4	QRSAG	QRS Duration, Aggregate	SLING	0.050	sec	50	50	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS		2008-10-28T07:46	-14	-14	Pretest	1	-P14D	Day 1 Dose	2008-11-11T08:54
5	TSA1397	EG	1	5	QRSAG	QRS Duration, Aggregate	SLING	0.038	sec	38	38	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS	Y	2008-12-03T09:05	23	23	Predose	2	-PT5M	Day 23 Dose	2008-12-03T09:10
6	TSA1397	EG	1	6	QRSAG	QRS Duration, Aggregate	SLING	0.039	sec	39	39	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS		2008-12-03T11:03	23	23	2 Hour Postdose	3	PT120M	Day 23 Dose	2008-12-03T09:10
7	TSA1397	EG	1	7	PPAG	PP Interval, Aggregate	SLING	0.073	sec	73	73	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS		2008-10-28T07:46	-14	-14	Pretest	1	-P14D	Day 1 Dose	2008-11-11T08:54
8	TSA1397	EG	1	8	PPAG	PP Interval, Aggregate	SLING	0.083	sec	83	83	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS	Y	2008-12-03T09:05	23	23	Predose	2	-PT5M	Day 23 Dose	2008-12-03T09:10
9	TSA1397	EG	1	9	PPAG	PP Interval, Aggregate	SLING	0.076	sec	76	76	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS		2008-12-03T11:03	23	23	2 Hour Postdose	3	PT120M	Day 23 Dose	2008-12-03T09:10
10	TSA1397	EG	1	10	QTAG	QT Interval, Aggregate	SLING	0.209	sec	209	209	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS		2008-10-28T07:46	-14	-14	Pretest	1	-P14D	Day 1 Dose	2008-11-11T08:54
11	TSA1397	EG	1	11	QTAG	QT Interval, Aggregate	SLING	0.222	sec	222	222	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS	Y	2008-12-03T09:05	23	23	Predose	2	-PT5M	Day 23 Dose	2008-12-03T09:10
12	TSA1397	EG	1	12	QTAG	QT Interval, Aggregate	SLING	0.192	sec	192	192	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS		2008-12-03T11:03	23	23	2 Hour Postdose	3	PT120M	Day 23 Dose	2008-12-03T09:10
13	TSA1397	EG	1	13	QTCFAG	QTcF Interval, Aggregate	SLING	0.238	sec	238	238	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS		2008-10-28T07:46	-14	-14	Pretest	1	-P14D	Day 1 Dose	2008-11-11T08:54
14	TSA1397	EG	1	14	QTAG	QT Interval, Aggregate	SLING	0.255	sec	255	255	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS	Y	2008-12-03T09:05	23	23	Predose	2	-PT5M	Day 23 Dose	2008-12-03T09:10
15	TSA1397	EG	1	15	QTAG	QT Interval, Aggregate	SLING	0.240	sec	240	240	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS		2008-12-03T11:03	23	23	2 Hour Postdose	3	PT120M	Day 23 Dose	2008-12-03T09:10
16	TSA1397	EG	1	16	QTCVAG	QTcV Interval, Aggregate	SLING	0.237	sec	237	237	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS		2008-10-28T07:46	-14	-14	Pretest	1	-P14D	Day 1 Dose	2008-11-11T08:54
17	TSA1397	EG	1	17	QTCVAG	QTcV Interval, Aggregate	SLING	0.252	sec	252	252	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS	Y	2008-12-03T09:05	23	23	Predose	2	-PT5M	Day 23 Dose	2008-12-03T09:10
18	TSA1397	EG	1	18	QTCVAG	QTcV Interval, Aggregate	SLING	0.234	sec	234	234	msec	LEAD II	6 LEAD STANDARD	CONSCIOUS		2008-12-03T11:03	23	23	2 Hour Postdose	3	PT120M	Day 23 Dose	2008-12-03T09:10

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Example

This example is for a cardiovascular assessment in telemetered animals where the results are averages derived by the equipment/device from multiple 1-hour intervals during a continuous 48-hour collection period. Means have been calculated from waveform data for 6 specific intervals within the entire collection period. A single planned dose, described in EGTPTREF, was given on day 1 at 06:15 (EGRFTDTC="2009-04-15T06:15"). The planned 1-hour intervals are represented by the start (EGSTINT) and end (EGENINT) of the evaluation relative to the referenced dose (EGTPTREF). Each of the 6 intervals has a text label (e.g., "Predose", "1 hr Postdose") indicated in the EGTPT variable. The applicant has defined the labels to be the end of the interval relative to the referenced dose. The entry in EGTPT is represented in ISO 8601 format in the EGELTM variable. The actual start and end date/time variables (EGDTC and EGENDTC) are the start and end of the evaluation interval, not the date and time of the entire continuous collection period.

Rows 1-4:	Results calculated using data from the 1-hour interval ending at the dose on study day 1.
Rows 5-8:	Results calculated using data from the 1-hour interval ending 1-hour post-dose administered on study day 1.
Rows 9-12:	Results calculated using data from the 1-hour interval ending 2-hours post-dose administered on study day 1.
Rows 13-16:	Results calculated using data from the 1-hour interval ending 3-hours post-dose administered on study day 1.
Rows 17-20:	Results calculated using data from the 1-hour interval ending 24-hours post-dose administered on study day 1.
Rows 21-24:	Results calculated using data from the 1-hour interval ending 48-hours post-dose administered on study day 1.

eg.xpt

Row	STUDYID	DOMAIN	USUBJID	EGSEQ	EGTESTCD	EGTEST	EGPOS	EGORRES	EGORRESU	EGSTRESC	EGSTRESN	EGSTRESU	EGLEAD	EGMETHOD	EGCSTATE	EGBLFL	EGDTC	EGDY	EGENDTC	EGENDY	EGNOMDY	EGTPT	EGTPTNUM	EGELTM	EGTPTREF	EGRFTDTC	EGSTINT	EGENINT
1	XYZ	EG	XYZ-001-001	1	RRAG	RR Interval, Aggregate	UNCONSTRAINED	248.11	msec	248.11	248.11	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS	Y	2009-04-15T05:12:15	1	2009-04-15T06:12:15	1	1	Predose	0	PT0H	DAY 1 DOSING	2009-04-15T06:15	-PT1H	PT0H
2	XYZ	EG	XYZ-001-001	2	EGHR	ECG Mean Heart Rate	UNCONSTRAINED	241.8	beats/min	241.8	241.8	beats/min	LEAD I	12 LEAD STANDARD	CONSCIOUS	Y	2009-04-15T05:12:15	1	2009-04-15T06:12:15	1	1	Predose	0	PT0H	DAY 1 DOSING	2009-04-15T06:15	-PT1H	PT0H
3	XYZ	EG	XYZ-001-001	3	QTAG	QT Interval, Aggregate	UNCONSTRAINED	132.17	msec	132.17	132.17	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS	Y	2009-04-15T05:12:15	1	2009-04-15T06:12:15	1	1	Predose	0	PT0H	DAY 1 DOSING	2009-04-15T06:15	-PT1H	PT0H
4	XYZ	EG	XYZ-001-001	4	QTCFAG	QTcF Interval, Aggregate	UNCONSTRAINED	211.91	msec	211.91	211.91	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS	Y	2009-04-15T05:12:15	1	2009-04-15T06:12:15	1	1	Predose	0	PT0H	DAY 1 DOSING	2009-04-15T06:15	-PT1H	PT0H
5	XYZ	EG	XYZ-001-001	5	RRAG	RR Interval, Aggregate	UNCONSTRAINED	354.13	msec	354.13	354.13	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-15T06:12:15	1	2009-04-15T07:12:15	1	1	1h Postdose	1	PT1H	DAY 1 DOSING	2009-04-15T06:15	PT0H	PT1H
6	XYZ	EG	XYZ-001-001	6	EGHR	ECG Mean Heart Rate	UNCONSTRAINED	169.4	beats/min	169.4	169.4	beats/min	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-15T06:12:15	1	2009-04-15T07:12:15	1	1	1h Postdose	1	PT1H	DAY 1 DOSING	2009-04-15T06:15	PT0H	PT1H
7	XYZ	EG	XYZ-001-001	7	QTAG	QT Interval, Aggregate	UNCONSTRAINED	150.19	msec	150.19	150.19	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-15T06:12:15	1	2009-04-15T07:12:15	1	1	1h Postdose	1	PT1H	DAY 1 DOSING	2009-04-15T06:15	PT0H	PT1H
8	XYZ	EG	XYZ-001-001	8	QTCFAG	QTcF Interval, Aggregate	UNCONSTRAINED	213.34	msec	213.34	213.34	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-15T06:12:15	1	2009-04-15T07:12:15	1	1	1h Postdose	1	PT1H	DAY 1 DOSING	2009-04-15T06:15	PT0H	PT1H
9	XYZ	EG	XYZ-001-001	9	RRAG	RR Interval, Aggregate	UNCONSTRAINED	363.43	msec	363.43	363.43	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-15T07:12:15	1	2009-04-15T08:12:15	1	1	2h Postdose	2	PT2H	DAY 1 DOSING	2009-04-15T06:15	PT1H	PT2H
10	XYZ	EG	XYZ-001-001	10	EGHR	ECG Mean Heart Rate	UNCONSTRAINED	165.1	beats/min	165.1	165.1	beats/min	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-15T07:12:15	1	2009-04-15T08:12:15	1	1	2h Postdose	2	PT2H	DAY 1 DOSING	2009-04-15T06:15	PT1H	PT2H
11	XYZ	EG	XYZ-001-001	11	QTAG	QT Interval, Aggregate	UNCONSTRAINED	150.82	msec	150.82	150.82	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-15T07:12:15	1	2009-04-15T08:12:15	1	1	2h Postdose	2	PT2H	DAY 1 DOSING	2009-04-15T06:15	PT1H	PT2H
12	XYZ	EG	XYZ-001-001	12	QTCFAG	QTcF Interval, Aggregate	UNCONSTRAINED	212.35	msec	212.35	212.35	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-15T07:12:15	1	2009-04-15T08:12:15	1	1	2h Postdose	2	PT2H	DAY 1 DOSING	2009-04-15T06:15	PT1H	PT2H
13	XYZ	EG	XYZ-001-001	13	RRAG	RR Interval, Aggregate	UNCONSTRAINED	361.04	msec	361.04	361.04	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-15T08:12:15	1	2009-04-15T09:12:15	1	1	3h Postdose	3	PT3H	DAY 1 DOSING	2009-04-15T06:15	PT2H	PT3H
14	XYZ	EG	XYZ-001-001	14	EGHR	ECG Mean Heart Rate	UNCONSTRAINED	166.2	beats/min	166.2	166.2	beats/min	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-15T08:12:15	1	2009-04-15T09:12:15	1	1	3h Postdose	3	PT3H	DAY 1 DOSING	2009-04-15T06:15	PT2H	PT3H
15	XYZ	EG	XYZ-001-001	15	QTAG	QT Interval, Aggregate	UNCONSTRAINED	149.01	msec	149.01	149.01	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-15T08:12:15	1	2009-04-15T09:12:15	1	1	3h Postdose	3	PT3H	DAY 1 DOSING	2009-04-15T06:15	PT2H	PT3H
16	XYZ	EG	XYZ-001-001	16	QTCFAG	QTcF Interval, Aggregate	UNCONSTRAINED	210.76	msec	210.76	210.76	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-15T08:12:15	1	2009-04-15T09:12:15	1	1	3h Postdose	3	PT3H	DAY 1 DOSING	2009-04-15T06:15	PT2H	PT3H
17	XYZ	EG	XYZ-001-001	17	RRAG	RR Interval, Aggregate	UNCONSTRAINED	360.23	msec	360.23	360.23	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-16T05:12:15	2	2009-04-16T06:12:15	2	1	24h Postdose	4	PT24H	DAY 1 DOSING	2009-04-15T06:15	PT23H	PT24H
18	XYZ	EG	XYZ-001-001	18	EGHR	ECG Mean Heart Rate	UNCONSTRAINED	166.6	beats/min	166.6	166.6	beats/min	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-16T05:12:15	2	2009-04-16T06:12:15	2	1	24h Postdose	4	PT24H	DAY 1 DOSING	2009-04-15T06:15	PT23H	PT24H
19	XYZ	EG	XYZ-001-001	19	QTAG	QT Interval, Aggregate	UNCONSTRAINED	147.98	msec	147.98	147.98	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-16T05:12:15	2	2009-04-16T06:12:15	2	1	24h Postdose	4	PT24H	DAY 1 DOSING	2009-04-15T06:15	PT23H	PT24H
20	XYZ	EG	XYZ-001-001	20	QTCFAG	QTcF Interval, Aggregate	UNCONSTRAINED	209.40	msec	209.40	209.40	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-16T05:12:15	2	2009-04-16T06:12:15	2	1	24h Postdose	4	PT24H	DAY 1 DOSING	2009-04-15T06:15	PT23H	PT24H
21	XYZ	EG	XYZ-001-001	21	RRAG	RR Interval, Aggregate	UNCONSTRAINED	259.89	msec	259.89	259.89	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-17T05:12:15	3	2009-04-17T06:12:15	3	1	48h Postdose	5	PT48H	DAY 1 DOSING	2009-04-15T06:15	PT47H	PT48H
22	XYZ	EG	XYZ-001-001	22	EGHR	ECG Mean Heart Rate	UNCONSTRAINED	230.9	beats/min	230.9	230.9	beats/min	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-17T05:12:15	3	2009-04-17T06:12:15	3	1	48h Postdose	5	PT48H	DAY 1 DOSING	2009-04-15T06:15	PT47H	PT48H
23	XYZ	EG	XYZ-001-001	23	QTAG	QT Interval, Aggregate	UNCONSTRAINED	133.67	msec	133.67	133.67	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-17T05:12:15	3	2009-04-17T06:12:15	3	1	48h Postdose	5	PT48H	DAY 1 DOSING	2009-04-15T06:15	PT47H	PT48H
24	XYZ	EG	XYZ-001-001	24	QTCFAG	QTcF Interval, Aggregate	UNCONSTRAINED	210.99	msec	210.99	210.99	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-04-17T05:12:15	3	2009-04-17T06:12:15	3	1	48h Postdose	5	PT48H	DAY 1 DOSING	2009-04-15T06:15	PT47H	PT48H

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

As previously noted, in the above example, the applicant has defined the interval labels to be the end of the interval relative to the referenced dose. However, applicants may label time points differently, such as from the beginning or midpoint of the interval, or use another form of labeling. In these cases, the period of evaluation (defined by EGSTINT and EGENINT) does not change, just the label (EGTPT) and its standard representation (EGELTM).

The following is a sampling of rows from the above example, with only the timing variables. Regardless of the method of labeling for the time points, the same periods of evaluation apply:

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eg.xpt

Row	EGDTC	EGDY	EGENDTC	EGENDY	EGNOMDY	EGTPT	EGTPTNUM	EGELTM	EGTPTREF	EGRFTDTC	EGSTINT	EGENINT
1	2009-04-15T05:12:15	1	2009-04-15T06:12:15	1	1	(see below)	0	(see below)	DAY 1 DOSING	2009-04-15T06:15	-PT1H	PT0H
5	2009-04-15T06:12:15	1	2009-04-15T07:12:15	1	1	(see below)	1	(see below)	DAY 1 DOSING	2009-04-15T06:15	PT0H	PT1H
9	2009-04-15T07:12:15	1	2009-04-15T08:12:15	1	1	(see below)	2	(see below)	DAY 1 DOSING	2009-04-15T06:15	PT1H	PT2H
13	2009-04-15T08:12:15	1	2009-04-15T09:12:15	1	1	(see below)	3	(see below)	DAY 1 DOSING	2009-04-15T06:15	PT2H	PT3H

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The following are variations on the time point labeling (EGTPT) and duration to the time point (EGELTM) for the same periods of evaluation.

End-based

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Row	EGTPT	EGELTM
1	Predose	PT0H
5	1h Postdose	PT1H
9	2h Postdose	PT2H
13	3h Postdose	PT3H

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In this case, intervals are labeled based on the end of the interval (e.g., the 1- to 2-hour post-dose interval is labeled as "2h Postdose"). This example is the same as that used in the full example above.

Start-based

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Row	EGTPT	EGELTM
1	-1 hour predose	-PT1H
5	0 hour postdose	PT0H
9	1 hour postdose	PT1H
13	2 hour postdose	PT2H

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In this case, intervals are labeled based on the start of the interval (e.g., the 1- to 2-hour post-dose interval is labeled as "1 hour postdose").

Midpoint-based

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Row	EGTPT	EGELTM
1	Predose	-PT30M
5	30 min	PT30M
9	1 hr 30 min	PT1H30M
13	2 hr 30 min	PT2H30M

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In this case, intervals are labeled based on the midpoint of the interval (e.g., the 1- to 2-hour post-dose interval is labeled as "1 hr 30 min").

Range Description

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Row	EGTPT	EGELTM
1	-1 to 0 hour post
5	0 to 1 hour post
9	1 to 2 hour post
13	2 to 3 hour post

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In this case, intervals are labeled based on the time range (e.g., the 1- to 2-hour post-dose interval is labeled as "1 to 2 hour post"). The time point does not have a determinate time from the reference point, so EGELTM is blank.

Example

This example shows how ECG measurements, interpretations, and diagnoses may be shown within the EG domain.

Rows 1-3:	Subject XYZ-001-001 had a QT measurement (row 1). The technician performed an interpretation, noting that the QT appeared abnormal (row 2). The cardiologist subsequently provided a diagnosis for the animal (row 3).
Rows 4-7:	Subject XYZ-001-002 had a T wave measurement (row 4). The ECG analyst performed an interpretation, noting a T wave inversion (row 5). The cardiologist subsequently provided 2 diagnoses for the animal, 1 a targeted assessment (row 6) and 1 a general assessment (row 7).

eg.xpt

Row	STUDYID	DOMAIN	USUBJID	EGSEQ	EGGRPID	EGTESTCD	EGTEST	EGCAT	EGPOS	EGORRES	EGORRESU	EGSTRESC	EGSTRESN	EGSTRESU	EGLEAD	EGMETHOD	EGCSTATE	EGEVAL	EGDTC	EGDY	EGNOMDY	EGTPT	EGTPTREF	EGRFTDTC
1	XYZ	EG	XYZ-001-001	1	1	QTAG	QT Interval, Aggregate	MEASUREMENT	UNCONSTRAINED	132.172	msec	132.172	132.172	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-01-15T06:00	1	1	Predose	Day 1 Dose	2009-01-15T07:00
2	XYZ	EG	XYZ-001-001	2	1	INTP	Interpretation	INTERPRETATION	UNCONSTRAINED	QT MEAN POSSIBLY ABNORMAL		QT MEAN POSSIBLY ABNORMAL						TECHNICIAN	2009-01-15T06:00	1	1	Predose	Day 1 Dose	2009-01-15T07:00
3	XYZ	EG	XYZ-001-001	3	1	INTP	Interpretation	DIAGNOSIS	UNCONSTRAINED	PROLONGED QT		PROLONGED QT						CARDIOLOGIST	2009-01-15T06:00	1	1	Predose	Day 1 Dose	2009-01-15T07:00
4	XYZ	EG	XYZ-001-002	1	2	TWARAG	T Wave Area, Aggregate	MEASUREMENT	UNCONSTRAINED	-211.905	msec	-211.905	-211.905	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS		2009-01-15T06:00	1	1	Predose	Day 1 Dose	2009-01-15T07:00
5	XYZ	EG	XYZ-001-002	2	2	INTP	Interpretation	INTERPRETATION	UNCONSTRAINED	T WAVE INVERSION		T WAVE ABNORMALITY						ECG ANALYST	2009-01-15T06:00	1	1	Predose	Day 1 Dose	2009-01-15T07:00
6	XYZ	EG	XYZ-001-002	3	2	INTP	Interpretation	DIAGNOSIS	UNCONSTRAINED	LEFT VENTRICULAR HYPERTROPHY		LEFT VENTRICULAR HYPERTROPHY						CARDIOLOGIST	2009-01-15T06:00	1	1	Predose	Day 1 Dose	2009-01-15T07:00
7	XYZ	EG	XYZ-001-002	4	2	INTP	Interpretation	DIAGNOSIS	UNCONSTRAINED	JUNCTIONAL TACHYCARDIA		JUNCTIONAL TACHYCARDIA						CARDIOLOGIST	2009-01-15T06:00	1	1	Predose	Day 1 Dose	2009-01-15T07:00

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

The study design for this example is to determine a suspected toxicity of the heart. The same test parameters were collected from different leads identifiers, using different methods, and summarized at different time points. The data is summarized for an hour-long interval after the day 1 dose, as indicated by EGSTINT and EGENINT.

Rows 1-4:	Demonstrate an animal in an unconstrained position (EGPOS) during data collection. The lead from which data were collected is lead CV5RL (EGLEAD), and the method of collection (EGMETHOD) was the 6-lead standard.
Rows 5-8:	Demonstrate an animal in a standing position (EGPOS) during data collection. The lead from which data were collected is lead II (EGLEAD), and the method of collection (EGMETHOD) was the 12-lead standard.
Rows 9-12:	Demonstrate an animal in an unconstrained position (EGPOS) during data collection. The lead from which data were collected is lead I (EGLEAD), and the method of collection (EGMETHOD) was the 12-lead standard.

eg.xpt

Row	STUDYID	DOMAIN	USUBJID	EGSEQ	EGTESTCD	EGTEST	EGPOS	EGORRES	EGORRESU	EGSTRESC	EGSTRESN	EGSTRESU	EGLEAD	EGMETHOD	EGCSTATE	EGDTC	EGDY	EGNOMDY	EGTPT	EGTPTNUM	EGELTM	EGTPTREF	EGRFTDTC	EGSTINT	EGENINT
1	XYZ	EG	XYZ-101-101	1	RRAG	RR Interval, Aggregate	UNCONSTRAINED	248.105	msec	248.105	248.105	msec	LEAD CV5RL	6 LEAD STANDARD	CONSCIOUS	2009-04-15T07:00	1	1	1H POSTDOSE	1	PT1H	Day 1 Dose	2009-04-15T06:00	PT0H	PT1H
2	XYZ	EG	XYZ-101-101	2	EGHRMN	ECG Mean Heart Rate	UNCONSTRAINED	241.833	beats/min	241.833	241.833	beats/min	LEAD CV5RL	6 LEAD STANDARD	CONSCIOUS	2009-04-15T07:00	1	1	1H POSTDOSE	1	PT1H	Day 1 Dose	2009-04-15T06:00	PT0H	PT1H
3	XYZ	EG	XYZ-101-101	3	QTAG	QT Interval, Aggregate	UNCONSTRAINED	132.172	msec	132.172	132.172	msec	LEAD CV5RL	6 LEAD STANDARD	CONSCIOUS	2009-04-15T07:00	1	1	1H POSTDOSE	1	PT1H	Day 1 Dose	2009-04-15T06:00	PT0H	PT1H
4	XYZ	EG	XYZ-101-101	4	QTCFAG	QTcF Interval, Aggregate	UNCONSTRAINED	211.905	msec	211.905	211.905	msec	LEAD CV5RL	6 LEAD STANDARD	CONSCIOUS	2009-04-15T07:00	1	1	1H POSTDOSE	1	PT1H	Day 1 Dose	2009-04-15T06:00	PT0H	PT1H
5	XYZ	EG	XYZ-201-201	5	RRAG	RR Interval, Aggregate	STANDING	354.13	msec	354.13	354.13	msec	LEAD II	12 LEAD STANDARD	CONSCIOUS	2009-04-15T07:00	1	1	1H POSTDOSE	1	PT1H	Day 1 Dose	2009-04-15T06:00	PT0H	PT1H
6	XYZ	EG	XYZ-201-201	6	EGHRMN	ECG Mean Heart Rate	STANDING	169.429	beats/min	169.429	169.429	beats/min	LEAD II	12 LEAD STANDARD	CONSCIOUS	2009-04-15T07:00	1	1	1H POSTDOSE	1	PT1H	Day 1 Dose	2009-04-15T06:00	PT0H	PT1H
7	XYZ	EG	XYZ-201-201	7	QTAG	QT Interval, Aggregate	STANDING	150.19	msec	150.19	150.19	msec	LEAD II	12 LEAD STANDARD	CONSCIOUS	2009-04-15T07:00	1	1	1H POSTDOSE	1	PT1H	Day 1 Dose	2009-04-15T06:00	PT0H	PT1H
8	XYZ	EG	XYZ-201-201	8	QTCFAG	QTcF Interval, Aggregate	STANDING	213.335	msec	213.335	213.335	msec	LEAD II	12 LEAD STANDARD	CONSCIOUS	2009-04-15T07:00	1	1	1H POSTDOSE	1	PT1H	Day 1 Dose	2009-04-15T06:00	PT0H	PT1H
9	XYZ	EG	XYZ-301-301	9	RRAG	RR Interval, Aggregate	UNCONSTRAINED	363.428	msec	363.428	363.428	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS	2009-04-15T07:00	1	1	1H POSTDOSE	1	PT1H	Day 1 Dose	2009-04-15T06:00	PT0H	PT1H
10	XYZ	EG	XYZ-301-301	10	EGHRMN	ECG Mean Heart Rate	UNCONSTRAINED	165.1	beats/min	165.1	165.1	beats/min	LEAD I	12 LEAD STANDARD	CONSCIOUS	2009-04-15T07:00	1	1	1H POSTDOSE	1	PT1H	Day 1 Dose	2009-04-15T06:00	PT0H	PT1H
11	XYZ	EG	XYZ-301-301	11	QTAG	QT Interval, Aggregate	UNCONSTRAINED	150.819	msec	150.819	150.819	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS	2009-04-15T07:00	1	1	1H POSTDOSE	1	PT1H	Day 1 Dose	2009-04-15T06:00	PT0H	PT1H
12	XYZ	EG	XYZ-301-301	12	QTCFAG	QTcF Interval, Aggregate	UNCONSTRAINED	212.351	msec	212.351	212.351	msec	LEAD I	12 LEAD STANDARD	CONSCIOUS	2009-04-15T07:00	1	1	1H POSTDOSE	1	PT1H	Day 1 Dose	2009-04-15T06:00	PT0H	PT1H

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