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Dataset wrap

title	cv.xpt
Name	CV

Dataset2

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVLOC	CVORRES	CVSTRESC	CVRESLOC	CVRESLOC Detail	CVMETHOD	VISITNUM	VISIT	TUDTC
1	ABC	CV	ABC-456	1			Abnormality Indicator	HEART	Y				TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
2	ABC	CV	ABC-456	2	mv regurgitation	ABNEXAM	Examination for Abnormality	HEART	Blood Regurgitation	Blood Regurgitation	Mitral Valve	From left ventricle into the left atrium	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27

The below example shows how to represent calcification diameter and severity from a sponsor defined criteria using the TR domain. The Mitral Valve Annulus identified in TU is severely calcified.

Dataset wrap

Name	TR

Dataset2

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	TRLNKID	TRTEST	TRCAT	TRORRES	TRORRESU	VISITNUM	VISIT	RSDTC
1	ABC	TR	ABC-456	1	mv calcification	Calcification Diameter		1.2	mm	1	BASELINE	2020-04-27
2	ABC	TR	ABC-456	2	mv calcification	Calcification Severity	Sponsor-defined Criteria	Severe		1	BASELINE	2020-04-27

Alternatively modeling all of the above in CV:

Dataset wrap

title	cv.xpt
Name	cv

Rowcaps

Rows 1-3:	Examination of the heart indicates calcified mitral valve annulus and mitral valve stenosis.
Rows 4-5:	Examination of the heart indicates regurgitation at the mitral valve, blood is regurgitating from the left ventricle into the left atrium.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVGRPID	CVTESTCD	CVTEST	CVLOC	CVORRES	CVORRESU	CVSTRESC	CVRESLOC	CVRESLOC Detail	CVMETHOD	VISITNUM	VISIT	CVDTC
1	ABC	CV	ABC-456	1		LESIONIND	Lesion Indicator	HEART	Y					TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
2	ABC	CV	ABC-456	2	mv calcification	ABNEXAM	Examination for Abnormality	HEART	Valvular Calcification		Valvular Calcification	Mitral Valve Annulus		TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
3	ABC	CV	ABC-456	3	mv stenosis	ABNEXAM	Examination for Abnormality	HEART	Valvular Stenosis		Valvular Stenosis	Mitral Valve		TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
4	ABC	CV	ABC-456	4			Abnormality Indicator	HEART						TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
5	ABC	CV	ABC-456	5	mv regurgitation	ABNEXAM	Examination for Abnormality	HEART	Blood Regurgitation		Blood Regurgitation	Mitral Valve	From left ventricle into the left atrium	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
6	ABC	CV	ABC-456	6	mv calcification		Calcification Diameter	Mitral Valve Annulus	1.2	mm				TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27

The following example shows how to model severity assessments of the identified lesions and abnormalities based on peer-reviewed, validated and published instruments (either copyrighted or public domain). Note these tests were originally created as a CVTESTs, if users are using SDTMIG versions prior to 3.4. Per SDTMIG 3.4, this is now considered as a grading scale and therefore should now be represented as CC/RS.

Dataset wrap

Name	RS

Rowcaps

Row 1:	Mitral valve stenosis is moderate.
Row 2:	Mitral valve regurgitation is severe.

Dataset2

Dataset wrap

Name	TR

Sponsor-defined Criteria

Dataset2


Row	STUDYID	DOMAIN	USUBJID	RSSEQ	TRLNKID	TRTEST	TRCAT	TRORRES	VISITNUM	VISIT	RSDTC
1	ABC	TR	ABC-456	1	mv calcification	Calcification Severity

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKID	RSTEST	RSCAT	RSORRES	VISITNUM	VISIT	RSDTC
1	ABC	RS(CC)	ABC-456	1	mv stenosis	VSC-Cardiac Valvular Stenosis Severity	VALVE STENOSIS CLASSIFICATION 2009 VERSION	Moderate	1	BASELINE	2020-04-27
2	ABC	RS(CC)	ABC-456	2	mv regurgitation	SNVRC-Cardiac Valvular Regurgitation Severity	SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003	Severe	1	BASELINE	2020-04-27

The below example shows how to represent calcification severity from a sponsor defined criteria using the TR domain. The Mitral Valve Annulus identified in TU is severely calcified.

Severe

1

BASELINE

2020-04-27

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