SDTM. Basic CMR Tests - Systolic Function

The demographics (DM) domain is used to represent information about the participants in a clinical study. For more information on this domain, see Section 5.2, Demographics (DM), of the SDTMIG v3.4.

dm.xpt

Row	STUDYID	DOMAIN	USUBJID	SUBJID	RFSTDTC	SITEID	BRTHDTC	AGE	AGEU	SEX	ARMCD	ARM	ACTARMCD	ACTARM
1	DMD-EF	DM	DMD-EF-01-101	101	2021-02-15T09:00	01	2013-02-07	8	YEARS	M	A	Drug A	A	Drug A
2	DMD-EF	DM	DMD-EF-01-102	102	2021-01-13T08:00	01	2006-05-01	14	YEARS	M	A	Drug A	A	Drug A
3	DMD-EF	DM	DMD-EF-01-103	103	2021-04-15T10:15	01	2001-07-10	19	YEARS	M	B	Drug B	B	Drug B
4	DMD-EF	DM	DMD-EF-01-104	104	2021-05-06T09:30	01	1999-01-15	22	YEARS	M	B	Drug B	B	Drug B

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For patients with DMD, it is important to record the height and weight since cardiac index and spirometry results are affected by body surface area (ref: https://www.ahajournals.org/doi/10.1161/CIRCIMAGING.115.003810). The vitals signs (VS) dataset contains measurements including but not limited to blood pressure, temperature, respiration, body surface area, body mass index, height and weight. For more information on domain see Section 6.3.13, Vital Signs (VS) in the SDTMIG v3.4.

vs.xpt

Row	STUDYID	DOMAIN	USUBJID	VSSEQ	VSTESTCD	VSTEST	VSORRES	VSORRESU	VSSTRESC	VSSTRESN	VSSTRESU	VISITNUM	VISIT	VSDTC
1	DMD-EF	VS	DMD-EF-01-101	1	HEIGHT	Height	47	in	119	119	cm	1	VISIT 1	2022-05-16
2	DMD-EF	VS	DMD-EF-01-101	2	WEIGHT	Weight	20	kg	20	20	kg	1	VISIT 1	2022-05-16
3	DMD-EF	VS	DMD-EF-01-101	3	HEIGHT	Height	52	in	132	132	cm	6	VISIT 6	2023-04-06
4	DMD-EF	VS	DMD-EF-01-101	4	WEIGHT	Weight	32	kg	32	32	kg	6	VISIT 6	2023-04-06

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The cardiovascular system findings (CV) domain contains physiological and morphological findings related to the cardiovascular system. For more information on this domain see Section 6.3.7.2, Cardiovascular System Findings (CV), of the SDTMIG v3.4.

Rows 1-8:	Show the baseline CMR ejection fraction measurements for the participant at visit 1.
Rows 9-16:	Show the CMR ejection fraction measurements for the participant at visit 6.

cv.xpt

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVLOC	CVMETHOD	VISITNUM	VISIT	CVDTC	CVDY
1	DMD-EF	CV	DMD-EF-01-101	1		ESV	End Systolic Volume	32	mL	32	32	mL	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
2	DMD-EF	CV	DMD-EF-01-101	2		EDV	End Diastolic Volume	95	mL	95	95	mL	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
3	DMD-EF	CV	DMD-EF-01-101	3	2	LVEF_C	Left Ventricular Ejection Fraction, Calculated	67	%	67	67	%	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
4	DMD-EF	CV	DMD-EF-01-101	4	2	CARDOUT	Cardiac Output	5.4	L/min	5.4	5.4	L/min	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
5	DMD-EF	CV	DMD-EF-01-101	5		ESV	End Systolic Volume	24	mL	24	24	mL	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
6	DMD-EF	CV	DMD-EF-01-101	6		EDV	End Diastolic Volume	90	mL	90	90	mL	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
7	DMD-EF	CV	DMD-EF-01-101	7	2	RVEF_C	Right Ventricular Ejection Fraction, Calculated	74	%	74	74	%	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
8	DMD-EF	CV	DMD-EF-01-101	8	2	CARDOUT	Cardiac Output	5.6	L/min	5.6	5.6	L/min	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
9	DMD-EF	CV	DMD-EF-01-101	9		ESV	End Systolic Volume	37	mL	37	37	mL	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-04-06	325
10	DMD-EF	CV	DMD-EF-01-101	10		EDV	End Diastolic Volume	94	mL	94	94	mL	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-04-06	325
11	DMD-EF	CV	DMD-EF-01-101	11	2	LVEF_C	Left Ventricular Ejection Fraction, Calculated	60	%	60	60	%	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-04-06	325
12	DMD-EF	CV	DMD-EF-01-101	12	2	CARDOUT	Cardiac Output	4.0	L/min	4.0	4.0	L/min	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-04-06	325
13	DMD-EF	CV	DMD-EF-01-101	13		ESV	End Systolic Volume	36	mL	36	36	mL	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-04-06	325
14	DMD-EF	CV	DMD-EF-01-101	14		EDV	End Diastolic Volume	93	mL	93	93	mL	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-04-06	325
15	DMD-EF	CV	DMD-EF-01-101	15	2	RVEF_C	Right Ventricular Ejection Fraction, Calculated	61	%	61	61	%	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-04-06	325
16	DMD-EF	CV	DMD-EF-01-101	16	2	CARDOUT	Cardiac Output	4.0	L/min	4.0	4.0	L/min	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-04-06	325

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

The lab test, N-Terminal ProB-type Natriuretic Peptide, is a biomarker used in heart failure and ejection fraction for diagnosis and treatment (ref: https://pubmed.ncbi.nlm.nih.gov/34918487/; ref: https://pubmed.ncbi.nlm.nih.gov/33039447/). These test results are represented in the laboratory test results (LB) domain. For more information on this domain, see Section 6.3.5.6, Laboratory Test Results (LB), in the SDTMIG 3.4.

Row 1:	Shows the results for the N-Terminal ProB-type Natriuretic Peptide test at visit 1.
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	LBLOBXFL	VISITNUM	VISIT	LBDTC	LBDY
1	DMD-EF	LB	DMD-EF-01-101	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	VISIT 1	2022-05-16	1
2	DMD-EF	LB	DMD-EF-01-101	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	2023-04-06	325

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

A related records (RELREC) dataset is used to show the relationship between the CV and LB domains. For more information on relating records, see Section 8.2.1, Related Records (RELREC) in the SDTMIG v3.4.

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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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