CV-Imaging Example 1, Cardiac Valvular Abnormality

TU Domain Definition and Scope

The Tumor/Lesion domains (TU, TR) represent data collected in clinical trials where sites of disease (e.g., tumors/lesions/locations of interest, lymph nodes, organs of interest in the assessment of the disease) are identified and then repeatedly measured/assessed at subsequent time points and often used in an evaluation of disease response(s).

Tumor/Lesion Identification (TU)

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Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	VISIT
1	ABC	PR	ABC-456	1	TRANSTHORACIC ECHOCARDIOGRAPHY	BASELINE

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The below examples show the identification of calcification in the mitral valve annulus as well as mitral valve stenosis (TU). It also shows mitral valve regurgitation (CV).

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.

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Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TULOC	TUORRES	TUSTRESC	TURESLOC	TUMETHOD	VISITNUM	VISIT	TUDTC
1	ABC	TU	ABC-456	1		LESIONIND	Lesion Indicator	HEART	Y			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
2	ABC	TU	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	TU	ABC-456	3	mv stenosis	ABNEXAM	Examination for Abnormality	HEART	Valvular Stenosis	Valvular Stenosis	Mitral Valve	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27

Dataset Debug Message

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Dataset Wrapper Debug Message

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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

Dataset Debug Messages

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Alternatively modeling all of the above in CV:

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.

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Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVLOC	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	SCSTRESU	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		ABNEXAM	Examination for Abnormality	HEART	Valvular Calcification		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	Valvular Stenosis		Mitral Valve		TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
4	ABC	CV	ABC-456	4		ABNIND	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	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 regurgitation	EFFRGOA	Effective Regurgitant Orifice Area		26	mm²	26	26	mm²			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
7	ABC	CV	ABC-456	7	mv regurgitation	MVRGF	Regurgitant Fraction		35	%	35	35	%			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
8	ABC	CV	ABC-456	8	mv regurgitation	MVRGF	Regurgitant Volume		36	mL/beat	36	36	mL/beat			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
9	ABC	CV	ABC-456	9	mv regurgitation	MVVCA	Vena Contracta Area		26	mm²	26	26	mm²			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
10	ABC	CV	ABC-456	10	mv regurgitation	MVVCW	Vena Contracta Width		58	mm	58	58	mm			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27

Dataset Debug Messages

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Dataset Wrapper Debug Message

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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.

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

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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	Moderate	1	BASELINE	2020-04-27

Dataset Debug Messages

There seem to be multiple domains (RS(CC)) present in the dataset.
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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