Examples for Cardiovascular (CV) Domain Model

The CV, ECG Test Results (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 shows different cardiovascular endpoints collected for 1 subject, including examples of both collected and derived baseline measurements. These endpoints were measured at a single point in time at 8 hours post-dose (CVELTM = "PT8H"), per the study protocol. Since the time point is not an interval with a planned start and end, CVSTINT and CVENINT are null.

Rows 1-2, 4-5:	Show measurements performed at a specific time. Note that the same test was performed multiple times on the same day for a subject. In this example, CVDTC is part of the natural key of the dataset (CVDTC contains both date and time), distinguishing one record from the next.
Rows 3, 6:	Represent the mean of the 2 previous rows, which make them derived records (CVDRVFL="Y"), and at the same time serve as baseline values (CVBLFL="Y"). CVDTC now contains information about the date (not time).
Row 7:	Shows an example of a measured baseline value. It is not derived (CVDRVFL is null).

cv.xpt

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVTESTCD	CVTEST	CVPOS	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVMETHOD	CVCSTATE	CVBLFL	CVDRVFL	CVDTC	CVDY	CVNOMDY	CVTPT	CVTPTNUM	CVELTM	CVTPTREF
1	ABC	CV	ABC-001-001	1	SYSBP	Systolic Blood Pressure	SITTING	154	mmHg	154	154	mmHg	External Cuff	CONSCIOUS			1999-06-19T08:45	1	1	8 hours postdose	1	PT8H	Day 1 Dose
2	ABC	CV	ABC-001-001	2	SYSBP	Systolic Blood Pressure	SITTING	152	mmHg	152	152	mmHg	External Cuff	CONSCIOUS			1999-06-19T09:00	1	1	8 hours postdose	1	PT8H	Day 1 Dose
3	ABC	CV	ABC-001-001	3	SYSBP	Systolic Blood Pressure	SITTING	153	mmHg	153	153	mmHg	External Cuff	CONSCIOUS	Y	Y	1999-06-19	1	1	8 hours postdose	1	PT8H	Day 1 Dose
4	ABC	CV	ABC-001-001	4	DIABP	Diastolic Blood Pressure	SITTING	44	mmHg	44	44	mmHg	External Cuff	CONSCIOUS			1999-06-19T08:45	1	1	8 hours postdose	1	PT8H	Day 1 Dose
5	ABC	CV	ABC-001-001	5	DIABP	Diastolic Blood Pressure	SITTING	48	mmHg	48	48	mmHg	External Cuff	CONSCIOUS			1999-06-19T09:00	1	1	8 hours postdose	1	PT8H	Day 1 Dose
6	ABC	CV	ABC-001-001	6	DIABP	Diastolic Blood Pressure	SITTING	46	mmHg	46	46	mmHg	External Cuff	CONSCIOUS	Y	Y	1999-06-19	1	1	8 hours postdose	1	PT8H	Day 1 Dose
7	ABC	CV	ABC-001-001	7	PULSEPR	Pulse Pressure	SITTING	107	mmHg	72	72	mmHg	External Cuff	CONSCIOUS	Y		1999-06-19	1	1	8 hours postdose	1	PT8H	Day 1 Dose

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Example

This example shows measurements on 2 animals at 3 time points (baseline, 120 minutes, 240 minutes) relative to the administration of the third dose level of a Latin square design (with CVTPTREF as "Dose 3"). At each time point, several measurements were assessed (arterial diastolic pressure, arterial heart rate, arterial mean blood pressure). Each measurement summarizes data collected for a planned evaluation interval of 60 minutes that ended at time 0 min, 120 min, and 240 min after the dose. Subject 1003 received the third dose level on day 15 of the study and subject 1008 received this dose level on day 1. The method "Intravascular" is used for measurements taken directly from the vasculature.

cv.xpt

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVTESTCD	CVTEST	CVPOS	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVMETHOD	CVCSTATE	CVBLFL	CVDTC	CVDY	CVNOMDY	CVTPT	CVTPTNUM	CVELTM	CVTPTREF	CVRFTDTC	CVSTINT	CVENINT
1	AA222	CV	1003	1	DIABP	Diastolic Blood Pressure	UNCONSTRAINED	50.94	mmHg	50.94	50.94	mmHg	Intravascular	CONSCIOUS	Y	2006-09-15	15	15	0 min	0	PT0M	Dose 3	2006-09-15T10:30	-PT60M	PT0M
2	AA222	CV	1003	2	DIABP	Diastolic Blood Pressure	UNCONSTRAINED	50.68	mmHg	50.68	50.68	mmHg	Intravascular	CONSCIOUS		2006-09-15	15	15	120 min	120	PT120M	Dose 3	2006-09-15T10:30	PT60M	PT120M
3	AA222	CV	1003	3	DIABP	Diastolic Blood Pressure	UNCONSTRAINED	49.37	mmHg	49.37	49.37	mmHg	Intravascular	CONSCIOUS		2006-09-15	15	15	240 min	240	PT240M	Dose 3	2006-09-15T10:30	PT180M	PT240M
4	AA222	CV	1003	4	HR	Heart Rate	UNCONSTRAINED	139.2	beats/min	139.2	139.2	beats/min	Intravascular	CONSCIOUS	Y	2006-09-15	15	15	0 min	0	PT0M	Dose 3	2006-09-15T10:30	-PT60M	PT0M
5	AA222	CV	1003	5	HR	Heart Rate	UNCONSTRAINED	128.3	beats/min	128.3	128.3	beats/min	Intravascular	CONSCIOUS		2006-09-15	15	15	120 min	120	PT120M	Dose 3	2006-09-15T10:30	PT60M	PT120M
6	AA222	CV	1003	6	HR	Heart Rate	UNCONSTRAINED	118.4	beats/min	118.4	118.4	beats/min	Intravascular	CONSCIOUS		2006-09-15	15	15	240 min	240	PT240M	Dose 3	2006-09-15T10:30	PT180M	PT240M
7	AA222	CV	1003	7	MAP	Mean Arterial Pressure	UNCONSTRAINED	66.96	mmHg	66.96	66.96	mmHg	Intravascular	CONSCIOUS	Y	2006-09-15	15	15	0 min	0	PT0M	Dose 3	2006-09-15T10:30	-PT60M	PT0M
8	AA222	CV	1003	8	MAP	Mean Arterial Pressure	UNCONSTRAINED	66.66	mmHg	66.66	66.66	mmHg	Intravascular	CONSCIOUS		2006-09-15	15	15	120 min	120	PT120M	Dose 3	2006-09-15T10:30	PT60M	PT120M
9	AA222	CV	1003	9	MAP	Mean Arterial Pressure	UNCONSTRAINED	65.99	mmHg	65.99	65.99	mmHg	Intravascular	CONSCIOUS		2006-09-15	15	15	240 min	240	PT240M	Dose 3	2006-09-15T10:30	PT180M	PT240M
10	AA1111	CV	1008	10	DIABP	Diastolic Blood Pressure	UNCONSTRAINED	34.11	mmHg	34.11	34.11	mmHg	Intravascular	CONSCIOUS	Y	2006-09-01	1	1	0 min	0	PT0M	Dose 3	2006-09-01T10:30	-PT60M	PT0M
11	AA1111	CV	1008	11	DIABP	Diastolic Blood Pressure	UNCONSTRAINED	28.63	mmHg	28.63	28.63	mmHg	Intravascular	CONSCIOUS		2006-09-01	1	1	120 min	120	PT120M	Dose 3	2006-09-01T10:30	PT60M	PT120M
12	AA1111	CV	1008	12	DIABP	Diastolic Blood Pressure	UNCONSTRAINED	28.96	mmHg	28.96	28.96	mmHg	Intravascular	CONSCIOUS		2006-09-01	1	1	240 min	240	PT240M	Dose 3	2006-09-01T10:30	PT180M	PT240M
13	AA1111	CV	1008	13	HR	Heart Rate	UNCONSTRAINED	186.1	beats/min	186.1	186.1	beats/min	Intravascular	CONSCIOUS	Y	2006-09-01	1	1	0 min	0	PT0M	Dose 3	2006-09-01T10:30	-PT60M	PT0M
14	AA1111	CV	1008	14	HR	Heart Rate	UNCONSTRAINED	168.3	beats/min	168.3	168.3	beats/min	Intravascular	CONSCIOUS		2006-09-01	1	1	120 min	120	PT120M	Dose 3	2006-09-01T10:30	PT60M	PT120M
15	AA1111	CV	1008	15	HR	Heart Rate	UNCONSTRAINED	150.8	beats/min	150.8	150.8	beats/min	Intravascular	CONSCIOUS		2006-09-01	1	1	240 min	240	PT240M	Dose 3	2006-09-01T10:30	PT180M	PT240M
16	AA1111	CV	1008	16	MAP	Mean Arterial Pressure	UNCONSTRAINED	53.48	mmHg	53.48	53.48	mmHg	Intravascular	CONSCIOUS	Y	2006-09-01	1	1	0 min	0	PT0M	Dose 3	2006-09-01T10:30	-PT60M	PT0M
17	AA1111	CV	1008	17	MAP	Mean Arterial Pressure	UNCONSTRAINED	47.67	mmHg	47.67	47.67	mmHg	Intravascular	CONSCIOUS		2006-09-01	1	1	120 min	120	PT120M	Dose 3	2006-09-01T10:30	PT60M	PT120M
18	AA1111	CV	1008	18	MAP	Mean Arterial Pressure	UNCONSTRAINED	46.48	mmHg	46.48	46.48	mmHg	Intravascular	CONSCIOUS		2006-09-01	1	1	240 min	240	PT240M	Dose 3	2006-09-01T10:30	PT180M	PT240M

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Example

This example shows heart rates for a single animal where the evaluation intervals changed across the study. The applicant chose to label its time points (CVTPT) based on the hours, minutes, and seconds of the planned time away from dose, based on the end of the evaluation interval.

Row 1:	The pre-dose was monitored for a period of 1 hour, summarized into a 1-hour increment.
Rows 2-9:	From the dose to 2 hours post-dose, the data were summarized in 15-minute increments.
Rows 10-13:	From 2 hours post-dose up to 6 hours post-dose, the data were summarized into 1-hour increments.
Rows 14-16:	From 6 hours post-dose up to 12 hours post-dose, the data were summarized into 2-hour increments.

cv.xpt

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVTESTCD	CVTEST	CVPOS	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVMETHOD	CVCSTATE	CVBLFL	CVDTC	CVDY	CVNOMDY	CVTPT	CVTPTNUM	CVELTM	CVTPTREF	CVRFTDTC	CVSTINT	CVENINT
1	ABC-123	CV	101	1	HR	Heart Rate	UNCONSTRAINED	162	beats/min	162	162	beats/min	Intravascular	CONSCIOUS	Y	2012-03-22	1	1	00:00:00	1	PT0M	Day 1 Dose	2012-03-22T09:52	-PT1H	PT0M
2	ABC-123	CV	101	2	HR	Heart Rate	UNCONSTRAINED	158	beats/min	158	158	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	00:15:00	2	PT15M	Day 1 Dose	2012-03-22T09:52	PT0M	PT15M
3	ABC-123	CV	101	3	HR	Heart Rate	UNCONSTRAINED	152	beats/min	152	152	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	00:30:00	3	PT30M	Day 1 Dose	2012-03-22T09:52	PT15M	PT30M
4	ABC-123	CV	101	4	HR	Heart Rate	UNCONSTRAINED	141	beats/min	141	141	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	00:45:00	4	PT45M	Day 1 Dose	2012-03-22T09:52	PT30M	PT45M
5	ABC-123	CV	101	5	HR	Heart Rate	UNCONSTRAINED	120	beats/min	120	120	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	01:00:00	5	PT1H	Day 1 Dose	2012-03-22T09:52	PT45M	PT1H
6	ABC-123	CV	101	6	HR	Heart Rate	UNCONSTRAINED	113	beats/min	113	113	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	01:15:00	6	PT1H15M	Day 1 Dose	2012-03-22T09:52	PT1H	PT1H15M
7	ABC-123	CV	101	7	HR	Heart Rate	UNCONSTRAINED	123	beats/min	123	123	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	01:30:00	7	PT1H30M	Day 1 Dose	2012-03-22T09:52	PT1H15M	PT1H30M
8	ABC-123	CV	101	8	HR	Heart Rate	UNCONSTRAINED	143	beats/min	143	143	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	01:45:00	8	PT1H45M	Day 1 Dose	2012-03-22T09:52	PT1H30M	PT1H45M
9	ABC-123	CV	101	9	HR	Heart Rate	UNCONSTRAINED	146	beats/min	146	146	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	02:00:00	9	PT2H	Day 1 Dose	2012-03-22T09:52	PT1H45M	PT2H
10	ABC-123	CV	101	10	HR	Heart Rate	UNCONSTRAINED	166	beats/min	166	166	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	03:00:00	10	PT3H	Day 1 Dose	2012-03-22T09:52	PT2H	PT3H
11	ABC-123	CV	101	11	HR	Heart Rate	UNCONSTRAINED	146	beats/min	146	146	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	04:00:00	11	PT4H	Day 1 Dose	2012-03-22T09:52	PT3H	PT4H
12	ABC-123	CV	101	12	HR	Heart Rate	UNCONSTRAINED	149	beats/min	149	149	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	05:00:00	12	PT5H	Day 1 Dose	2012-03-22T09:52	PT4H	PT5H
13	ABC-123	CV	101	13	HR	Heart Rate	UNCONSTRAINED	123	beats/min	123	123	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	06:00:00	13	PT6H	Day 1 Dose	2012-03-22T09:52	PT5H	PT6H
14	ABC-123	CV	101	14	HR	Heart Rate	UNCONSTRAINED	105	beats/min	105	105	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	08:00:00	14	PT8H	Day 1 Dose	2012-03-22T09:52	PT6H	PT8H
15	ABC-123	CV	101	15	HR	Heart Rate	UNCONSTRAINED	100	beats/min	100	100	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	10:00:00	15	PT10H	Day 1 Dose	2012-03-22T09:52	PT8H	PT10H
16	ABC-123	CV	101	16	HR	Heart Rate	UNCONSTRAINED	113	beats/min	113	113	beats/min	Intravascular	CONSCIOUS		2012-03-22	1	1	12:00:00	16	PT12H	Day 1 Dose	2012-03-22T09:52	PT10H	PT12H

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Examples for Cardiovascular (CV) Domain Model