SDTM. Ejection Fraction

This example dataset shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to ejection fraction. CVDTC is the date of the CMR procedure, CVDY is the study. For the purposes of this example, the participant was enrolled in the study on 20-May-2021 and the study visits were every twp months.

cv.xpt

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVMETHOD	VISITNUM	VISIT	CVDTC	CVDY
1	DMD-EF	CV	101	1		RVESV	Right Ventricle Systolic Volume	39	mL	39	39	mL	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
2	DMD-EF	CV	101	2		RVEDV	Right Ventricle Diastolic Volume	115	mL	115	115	mL	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
3	DMD-EF	CV	101	3	2	RVEF_C	Right Ventricular Ejection Fraction, Calculated	66	%	66	66	%	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
4	DMD-EF	CV	101	4		LVESV	Left Ventricle Systolic Volume	20	mL	20	20	mL	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
5	DMD-EF	CV	101	5		LVEDV	Left Ventricle Diastolic Volume	100	mL	100	100	mL	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
6	DMD-EF	CV	101	6	2	LVEF_C	Left Ventricular Ejection Fraction, Calculated	50	%	50	50	%	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
7	DMD-EF	CV	101	7	2	LVCO	LV Cardiac Output	4.5	L/min	4.5	4.5	L/min	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
1	DMD-EF	CV	101	8		RVESV	Right Ventricle Systolic Volume	39	mL	39	39	mL	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
2	DMD-EF	CV	101	9		RVEDV	Right Ventricle Diastolic Volume	115	mL	115	115	mL	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
3	DMD-EF	CV	101	10	2	RVEF_C	Right Ventricular Ejection Fraction, Calculated	66	%	66	66	%	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
4	DMD-EF	CV	101	11		LVESV	Left Ventricle Systolic Volume	20	mL	20	20	mL	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
5	DMD-EF	CV	101	12		LVEDV	Left Ventricle Diastolic Volume	100	mL	100	100	mL	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
6	DMD-EF	CV	101	13	2	LVEF_C	Left Ventricular Ejection Fraction, Calculated	50	%	50	50	%	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
7	DMD-EF	CV	101	14	2	LVCO	LV Cardiac Output	4.5	L/min	4.5	4.5	L/min	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376

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Row 1:	Shows the results for the N-Terminal ProB-type Natriuretic Peptide test for subject 101 at Screening.
Row 2:	Shows the results for the N-Terminal ProB-type Natriuretic Peptide test at Visit 6.

lb.xpt

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBLNKID	LBTESTCD	LBTEST	LBCAT	LBORRES	LBORRESU	LBORNRLO	LBORNRHI	LBSTRESC	LBSTRESN	LBSTRESU	LBSTNRLO	LBSTRNHI	LBNRIND	LBLOINC	LBSPEC	VISITNUM	VISIT	LBDTC	LBDY
1	DMD-EF	LB	101	1	2	BNPPRONT	N-Terminal ProB-type Natriuretic Peptide	CHEMISTRY	40	pg/mL	0	100	40	40	IU/L	100	40	NORMAL	71425-3	BLOOD	1	SCREENING	2022-05-16
2	DMD-EF	LB	101	2	2	BNPPRONT	N-Terminal ProB-type Natriuretic Peptide	CHEMISTRY	900	pg/mL	0	100	900	900	IU/L	100	900	HIGH	71425-3	BLOOD	6	VISIT 6	2023-06-01	376

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The relationship between CV and LB is represented in the Related Records dataset (RELREC) . For more information on relating records, see the SDTMIG v3.4, Section 8.2.1.

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relrec.xpt

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	RELTYPE	RELID
1	DMD-EF	CV		CVLNKID		MANY	2
2	DMD-EF	LB		LBLNKID		ONE	2

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