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The demographics 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. Note there are 4 participants noted in this dataset while the other datasets only have one participant. This purpose is to show an example of the demographics datasetDM dataset; test results are shown for 1 participant.

Dataset wrap

Name	dm

Dataset2

Row	STUDYID	DOMAIN	USUBJID	SUBJID	RFSTDTC	RFICDTC	DTHDTC	DTHFL	SITEID	BRTHDTC	AGE	AGEU	SEX	RACE	ARMCD	ARM	ACTARMCD	ACTARM	COUNTRY
1	DMD-EF	DM	DMD-EF-01-101	101	2022-05-16T09:00	2022-05-16			01	20132010-02-07	812	YEARS	M	BLACK OR AFRICAN AMERICAN	A	Drug A	A	Drug A	USA
2	DMD-EF	DM	DMD-EF-01-102	102	2022-06-13T08:00	2022-06-13			01	20062008-05-01	14	YEARS	M	ASIAN	A	Drug A	A	Drug A	MYS
3	DMD-EF	DM	DMD-EF-01-103	103	2022-07-15T10:15	2022-07-15			01	20012003-07-10	19	YEARS	M	NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	B	Drug B	B	Drug B	BRA
4	DMD-EF	DM	DMD-EF-01-104	104	2022-09-06T09:30	2022-09-06	2023-11-23	Y	01	1999-01-15	2223	YEARS	M	WHITE	B	Drug B	B	Drug B	IRL

For patients with DMD, it It is important to record the height and weight for patients with DMD 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 .[2] The Vital 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 v3.4The height in the population may be estimated from the ulna length measuring between the point of the elbow and the midpoint of the prominent bone of the wrist.

Dataset wrap

Name	VS

Dataset2

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

The cardiovascular system findings 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.

Dataset wrap

Name	cv

Rowcaps

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.

Dataset2

tableid	cv

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 IMAGINGMRI	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 IMAGINGMRI	1	VISIT 1	2022-05-16	1
3	DMD-EF	CV	DMD-EF-01-101	3	2-1	LVEF_C	Left Ventricular Ejection Fraction, CalculatedCal	6770	%	677067	70	%	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGINGMRI	1	VISIT 1	2022-05-16	1
4	DMD-EF	CV	DMD-EF-01-101	4	2-1	CARDOUT	Cardiac Output	5.4	L/min	5.4	5.4	L/min	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGINGMRI	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 IMAGINGMRI	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 IMAGINGMRI	1	VISIT 1	2022-05-16	1
7	DMD-EF	CV	DMD-EF-01-101	7	2-1	RVEF_C	Right Ventricular Ejection Fraction, CalculatedCal	7475	%	747574	75	%	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGINGMRI	1	VISIT 1	2022-05-16	1
8	DMD-EF	CV	DMD-EF-01-101	8	2-1	CARDOUT	Cardiac Output	5.6	L/min	5.6	5.6	L/min	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGINGMRI	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 IMAGINGMRI	6	VISIT 6	2023-04-06	325326
10	DMD-EF	CV	DMD-EF-01-101	10		EDV	End Diastolic Volume	94	mL	94	94	mL	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGINGMRI	6	VISIT 6	2023-04-06	325326
11	DMD-EF	CV	DMD-EF-01-101	11	2-2	LVEF_C	Left Ventricular Ejection Fraction, CalculatedCal	6065	%	606560	65	%	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGINGMRI	6	VISIT 6	2023-04-06	325326
12	DMD-EF	CV	DMD-EF-01-101	12	2-2	CARDOUT	Cardiac Output	4.0	L/min	4.0	4.0	L/min	HEART, LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGINGMRI	6	VISIT 6	2023-04-06	325326
13	DMD-EF	CV	DMD-EF-01-101	13		ESV	End Systolic Volume	36	mL	36	36	mL	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGINGMRI	6	VISIT 6	2023-04-06	325326
14	DMD-EF	CV	DMD-EF-01-101	14		EDV	End Diastolic Volume	93	mL	93	93	mL	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGINGMRI	6	VISIT 6	2023-04-06	325326
15	DMD-EF	CV	DMD-EF-01-101	15	2-2	RVEF_C	Right Ventricular Ejection Fraction, CalculatedCal	6170	%	617061	70	%	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGINGMRI	6	VISIT 6	2023-04-06	325326
16	DMD-EF	CV	DMD-EF-01-101	16	2-2	CARDOUT	Cardiac Output	4.0	L/min	4.0	4.0	L/min	HEART, RIGHT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGINGMRI	6	VISIT 6	2023-04-06	325326

The lab test, N-terminal pro-Terminal ProBB-type Natriuretic Peptidenatriuretic peptide (NT-proBNP), 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/). .[3,4] 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.domain.

Dataset wrap

Name	lb

Rowcaps

Row 1:	Shows the results for the N-Terminal ProB-type Natriuretic Peptide NT-proBNP test at visit 1.
Row 2:	Shows the results for the N-Terminal ProB-type Natriuretic Peptide NT-proBNP test at visit 6.

Dataset2

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	2-1	BNPPRONT	N-Terminal ProB-type Natriuretic Peptide	CHEMISTRY	40	pg/mL	0	100	40	40	IUng/L	0	100	40	NORMAL	71425-3	BLOOD		1	VISIT 1	2022-05-16	1
2	DMD-EF	LB	DMD-EF-01-101	2	2-2	BNPPRONT	N-Terminal ProB-type Natriuretic Peptide	CHEMISTRY	900	pg/mL	0	100	900	900	IUng/L	0	100900	HIGH	71425-3	BLOOD		6	VISIT 6	2023-04-06	325326

A related records 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.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-18

Jira

showSummary	false
server	Issue Tracker (JIRA)
columnIds	issuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution
columns	key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-19

Dataset wrap

Name	relrec

Dataset2

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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