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The Demographics (DM) domain is used to represent information about the participants in a clinical study. Note there are 4 participants in this DM 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	2010-02-07	12	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	2008-05-01	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	2003-07-10	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	23	YEARS	M	WHITE	B	Drug B	B	Drug B	IRL

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.[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. The 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 (CV) domain contains physiological and morphological findings related to the cardiovascular systemThis 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.The CVLNKID variable is used to identify a record to show a relationship between records in separate domains.

Dataset wrap

Name	cv

Rowcaps

Rows 1-8:	Show the baseline CMR ejection fraction measurements for the participant 101 at Screeningvisit 1.
Rows 9-16:	Show the CMR ejection fraction measurements for the participant 101 at VISIT visit 6.

Dataset2

tableid	cv

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVLOC	CVMETHOD	CVLOBXFL	VISITNUM	VISIT	CVDTC	CVDY
1	DMD-EF	CV	DMD-EF-01-101	1

LVESV

ESV

Left Ventricle

End Systolic Volume

32

mL

32

mL

CARDIAC MAGNETIC RESONANCE IMAGING

HEART, LEFT VENTRICLE

MRI

1

SCREENING

VISIT 1	2022-05-16	1
2	DMD-EF	CV	DMD-EF-01-101	2

LVEDV

EDV

Left Ventricle

End Diastolic Volume

95

mL

95

mL

HEART, LEFT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING

1

SCREENING

VISIT 1	2022-05-16	1
3	DMD-EF	CV	DMD-EF-01-101	3	2-1	LVEF_C	Left Ventricular Ejection Fraction,

Calculated

Cal

67

70

%

67

70

67

70

%

CARDIAC MAGNETIC RESONANCE IMAGING

HEART, LEFT VENTRICLE

MRI

1

SCREENING

VISIT 1	2022-05-16	1
4	DMD-EF	CV	DMD-EF-01-101	4	2-1

LVCO

CARDOUT

LV

Cardiac Output

5.4

L/min

5.4

L/min

HEART, LEFT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING

1

SCREENING

VISIT 1	2022-05-16	1
5	DMD-EF	CV	DMD-EF-01-101	5

RVESV

ESV

Right Ventricle

End Systolic Volume

24

mL

24

mL

CARDIAC MAGNETIC RESONANCE IMAGING

HEART, RIGHT VENTRICLE

MRI

1

SCREENING

VISIT 1	2022-05-16	1
6	DMD-EF	CV	DMD-EF-01-101	6

RVEDV

EDV

Right Ventricle

End Diastolic Volume

90

mL

90

mL

CARDIAC MAGNETIC RESONANCE IMAGING

HEART, RIGHT VENTRICLE

MRI

1

SCREENING

VISIT 1	2022-05-16	1
7	DMD-EF	CV	DMD-EF-01-101	7	2-1	RVEF_C	Right Ventricular Ejection Fraction,

Calculated

Cal

74

75

%

74

75

74

75

%

CARDIAC MAGNETIC RESONANCE IMAGING

HEART, RIGHT VENTRICLE

MRI

1

SCREENING

VISIT 1	2022-05-16	1
8	DMD-EF	CV	DMD-EF-01-101	8	2-1

RVCO

CARDOUT

RV

Cardiac Output

5.6

L/min

5.6

L/min

CARDIAC MAGNETIC RESONANCE IMAGING

HEART, RIGHT VENTRICLE

MRI

1

SCREENING

VISIT 1	2022-05-16	1
9	DMD-EF	CV	DMD-EF-01-101	9

LVESV

ESV

Left Ventricle

End Systolic Volume

37

mL

37

mL

HEART, LEFT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING

6

VISIT 6

2023-04-06

-01

376

326
10	DMD-EF	CV	DMD-EF-01-101	10

LVEDV

EDV

Left Ventricle

End Diastolic Volume

94

mL

94

mL

CARDIAC MAGNETIC RESONANCE IMAGING

HEART, LEFT VENTRICLE

MRI

6

VISIT 6

2023-04-06

-01

376

326
11	DMD-EF	CV	DMD-EF-01-101	11	2-2	LVEF_C	Left Ventricular Ejection Fraction,

Calculated

Cal

60

65

%

60

65

60

65

%

HEART, LEFT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING

6

VISIT 6

2023-04-06

-01

376

326
12	DMD-EF	CV	DMD-EF-01-101	12	2-2

LVCO

CARDOUT

LV

Cardiac Output

4.0

L/min

4.0

L/min

HEART, LEFT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING

6

VISIT 6

2023-04-06

-01

376

326
13	DMD-EF	CV	DMD-EF-01-101	13

RVESV

ESV

Right Ventricle

End Systolic Volume

36

mL

36

mL

HEART, RIGHT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING

6

VISIT 6

2023-04-06

-01

376

326
14	DMD-EF	CV	DMD-EF-01-101	14

RVEDV

EDV

Right Ventricle

End Diastolic Volume

93

mL

93

mL

HEART, RIGHT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING

6

VISIT 6

2023-04-06

-01

376

326
15	DMD-EF	CV	DMD-EF-01-101	15	2-2	RVEF_C	Right Ventricular Ejection Fraction,

Calculated

Cal

61

70

%

61

70

61

70

%

HEART, RIGHT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING

6

VISIT 6

2023-04-06

-01

376

326
16	DMD-EF	CV	DMD-EF-01-101	16	2-2

RVCO

CARDOUT

RV

Cardiac Output

4.0

L/min

4.0

L/min

HEART, RIGHT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING

6

VISIT 6

2023-04-06

-01376

326

The lab test, N-terminal pro-B-type natriuretic peptide (NT-proBNP), is a biomarker used in heart failure and ejection fraction for diagnosis and treatment.[3,4] These test results are represented in the Laboratory Test Results (LB) domain.

Dataset wrap

Name	lb

Rowcaps

Row 1:	Shows the results for the N-Terminal ProB-type Natriuretic Peptide test for participant 101 at ScreeningNT-proBNP test at visit 1.
Row 2:	Shows the results for the N-Terminal ProB-type Natriuretic Peptide NT-proBNP test at Visit 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	10040	NORMAL	7142571425-3	BLOOD		1SCREENING	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	2023-04-06-01	376	326

A Related Records (RELREC) dataset is used to show the 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.the CV and LB domains.

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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