Page History

...

Dataset wrap

title	cv.xpt
Name	cv

Rowcaps

Rows 1-4:	Examination of the heart indicates calcified mitral valve annulus and mitral valve stenosis, as well as regurgitation.
Rows 5-8:	Show the various measurements of the regurgitant jet, which are used for the MV regurgitation severity assessment in RS.
Rows 9-11:	Examination of the heart indicates flail aortic cusp and aortic valve stenosis, as well as regurgitation.
Rows 5-8:	Show the various measurements of the regurgitant jet, which are used for the MV regurgitation severity assessment in RS.

Dataset2

BASELINE15

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVGRPID	CVTESTCD	CVTEST	CVLOC	CVORRES	CVORRESU	CVSTRESC	CVSTRESNSCSTRESU	CVRESLOC	CVRESLOC Detail	CVMETHOD	VISITNUM	VISIT	CVDTC
1	ABC	CV	ABC-456	1			ABNIND	Abnormality Indicator	HEART	Y	Y	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	Valvular Calcification	Mitral Valve Annulus		TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
3	ABC	CV	ABC-456	3	1	mv stennosis	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	2	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
5	ABC	CV	ABC-456	5	2	mv regurgitation	EFFRGOA	Effective Regurgitant Orifice Area	26	mm2	26	26	mm2	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27	6	ABC	CV	ABC-456	6	2	mv regurgitation	MVRGF	Regurgitant Fraction	35	%	35	35	%	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27	7	ABC	CV	ABC-456	7	2	mv regurgitation	MVRGF	Regurgitant Volume	36	mL/beat	36	36	mL/beat	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27	8	ABC	CV	ABC-456	8	2	mv regurgitation	MVVCA	Vena Contracta Area	26	mm2	26	26	mm2	TRANSTHORACIC ECHOCARDIOGRAPHY	1		2020-04-27	9	ABC	CV	ABC-456	2		av cusp	ABNEXAM	Examination for Abnormality	HEART	Flail Cusp	Flail Cusp	Flail Cusp	Aortic Valve, Right Coronary Cusp		TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
106	ABC	CV	ABC-456	6	3	av stenosis	ABNEXAM	Examination for Abnormality	HEART	Valvular Stenosis	Valvular Stenosis	Valvular Stenosis	Aortic Valve		TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
117	ABC	CV	ABC-456	7	4	3	av regurgitation	ABNEXAM	Examination for Abnormality	HEART	Blood Regurgitation	Blood Regurgitation	Blood Regurgitation	Aortic Valve	From aorta to left ventricle	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27	12	ABC	CV	ABC-456	5	3	av regurgitation	EFFRGOA	Effective Regurgitant Orifice Area	15	mm2	15	15	mm2	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27	13	ABC	CV	ABC-456	6	3	av regurgitation	MVRGF	Regurgitant Fraction	20	%	20	20	%	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27	14	ABC	CV	ABC-456	7	3	av regurgitation	MVRGF	Regurgitant Volume	277	mL/beat	27	27	mL/beat	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27		ABC	CV	ABC-456	8	3	av regurgitation	MVVCA	Vena Contracta Area	22	mm2	22	22	mm2	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 severemoderate.
Rows 3-4:	Aortic valve regurgitation and stenosis are mild.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKID	RSTEST	RSCAT	RSORRES	VISITNUM	VISIT	RSDTC
1	ABC	RS(CC)	ABC-456	1	1	VSC-Cardiac Valvular Stenosis Severity: Mitral Valve	VALVE STENOSIS CLASSIFICATION 2009 VERSION	Moderate	1	BASELINE	2020-04-27
2	ABC	RS(CC)	ABC-456	2	2	SNVRC-Cardiac Valvular Regurgitation Severity: Mitral Valve	SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003	Moderate	1	BASELINE	2020-04-27
3	ABC	RS(CC)	ABC-456	3	3	VSC-Cardiac Valvular Stenosis Severity: Aortic Valve	VALVE STENOSIS CLASSIFICATION 2009 VERSION	Mild	1	BASELINE	2020-04-27
4	ABC	RS(CC)	ABC-456	4	4	SNVRC-Cardiac Valvular Regurgitation Severity: Aortic Valve	SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003	Mild	1	BASELINE	2020-04-27

...

Space shortcuts

Page tree

Versions Compared

Old Version 56

New Version Current

Key