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)

$titleHtml

pr.xpt

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

$warningHtml

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.

tu.xpt

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

Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

cv.xpt

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

There is a leading, trailing, or non-breaking space in the dataset.
Please remove all formatting (see How to Clear Formatting).

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.

cv.xpt

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	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	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	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			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	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	Mitral Valve	26	mm²				TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
7	ABC	CV	ABC-456	7		mv regurgitation	MVRGF	Mitral Valve Regurgitant Fraction		35	%				TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
8	ABC	CV	ABC-456	8		mv regurgitation	MVRGF	Mitral Valve Regurgitant Volume		36	mL/beat				TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
9	ABC	CV	ABC-456	9		mv regurgitation	MVVCA	Mitral Valve Vena Contracta Area		26	mm²				TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
10	ABC	CV	ABC-456	10		mv regurgitation	MVVCW	Mitral Valve Vena Contracta Width		58	mm				TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27

Dataset Debug Messages

There is a leading, trailing, or non-breaking space in the dataset.
Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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.

$titleHtml

rs.xpt

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.
Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

	File	Modified

No files shared here yet.

Space shortcuts

Page tree