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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
Namedm
Dataset2
RowSTUDYIDDOMAINUSUBJIDSUBJIDRFSTDTCRFENDTCRFXSTDTCRFXENDTCRFICDTCRFPENDTCDTHDTCDTHFLSITEIDBRTHDTCAGEAGEUSEXRACEARMCDARMACTARMCDACTARMARMNRSACTARMUDCOUNTRY
1DMD-EFDMDMD-EF-01-1011012022-05-16T09:00


2022-05-16


012010-02-0712YEARSMBLACK OR AFRICAN AMERICANADrug AADrug A

USA
2DMD-EFDMDMD-EF-01-1021022022-06-13T08:00


2022-06-13


012008-05-0114YEARSMASIANADrug AADrug A

MYS
3DMD-EFDMDMD-EF-01-1031032022-07-15T10:15


2022-07-15


012003-07-1019YEARSMNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERBDrug BBDrug B

BRA
4DMD-EFDMDMD-EF-01-1041042022-09-06T09:30


2022-09-06
2023-11-23Y011999-01-1523YEARSMWHITEBDrug BBDrug 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
NameVS
Dataset2
RowSTUDYIDDOMAINUSUBJIDVSSEQVSTESTCDVSTESTVSPOSVSORRESVSORRESUVSSTRESCVSSTRESNVSSTRESUVSLOBFXLVISITNUMVISITVSDTC
1DMD-EFVSDMD-EF-01-1011HEIGHTHeightSTANDING47in119119cm
1VISIT 12022-05-16
2DMD-EFVSDMD-EF-01-1012WEIGHTWeightSTANDING20kg2020kg
1VISIT 12022-05-16
3DMD-EFVSDMD-EF-01-1013HEIGHTHeightSTANDING52in132132cm
6VISIT 62023-04-06
4DMD-EFVSDMD-EF-01-1014WEIGHTWeightSTANDING32kg3232kg
6VISIT 62023-04-06

The Cardiovascular System Findings (CV) domain contains physiological and morphological findings related to the cardiovascular system.

Dataset wrap
Namecv
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
tableidcv
RowSTUDYIDDOMAINUSUBJIDCVSEQCVLNKIDCVTESTCDCVTESTCVORRESCVORRESUCVSTRESCCVSTRESNCVSTRESUCVLOCCVMETHODCVLOBXFLVISITNUMVISITCVDTCCVDY
1DMD-EFCVDMD-EF-01-1011
RVESV

ESV

Right Ventricle
End Systolic Volume
39
32mL
39
32
39
32mL
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, LEFT VENTRICLEMRI
1
SCREENING
VISIT 12022-05-161
2DMD-EFCVDMD-EF-01-1012
RVEDV

EDV

Right Ventricle
End Diastolic Volume
115
95mL
115
95
115
95mL
HEART, LEFT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING


1
SCREENING
VISIT 12022-05-161
3DMD-EFCVDMD-EF-01-10132-1
RVEF
LVEF_C
Right
Left Ventricular Ejection Fraction,
Calculated
Cal
66
70%
66
70
66
70%
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, LEFT VENTRICLEMRI
1
SCREENING
VISIT 12022-05-161
4DMD-EFCVDMD-EF-01-1014

LVESV

Left Ventricle Systolic Volume20mL2020mLCARDIAC MAGNETIC RESONANCE IMAGING1
2-1CARDOUTCardiac Output5.4L/min5.45.4L/minHEART, LEFT VENTRICLE

MRI


1VISIT 12022-05-161
5DMD-EFCVDMD-EF-01-1015

ESV

End Systolic Volume24mL2424mLHEART, RIGHT VENTRICLE

MRI


1VISIT 1
SCREENING
2022-05-16
5
1
6DMD-EFCVDMD-EF-01-101
5
6
LVEDV

EDV

Left Ventricle
End Diastolic Volume
100
90mL
100
90
100
90mL
HEART, RIGHT VENTRICLEMRI
CARDIAC MAGNETIC RESONANCE IMAGING

1
SCREENING
VISIT 12022-05-161
6
7DMD-EFCVDMD-EF-01-101
6
72-1
LVEF
RVEF_C
Left
Right Ventricular Ejection Fraction,
Calculated
Cal
50
75%
50
75
50
75%
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, RIGHT VENTRICLE

MRI


1
SCREENING
VISIT 12022-05-16
7
1
8DMD-EFCVDMD-EF-01-101
7
82-1
LVCO
CARDOUT
LV
Cardiac Output
4
5.
5
6L/min
4
5.65
4
.
5
6L/min
HEART, RIGHT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING


1
SCREENING
VISIT 12022-05-161
9DMD-EFCVDMD-EF-01-101
8
9
RVESV

ESV

Right Ventricle
End Systolic Volume
39
37mL
39
37
39
37mL
HEART, LEFT VENTRICLEMRI
CARDIAC MAGNETIC RESONANCE IMAGING

6VISIT 62023-04-06
-01
376
326
2
10DMD-EFCVDMD-EF-01-101
9
10
RVEDV

EDV

Right Ventricle
End Diastolic Volume
115
94mL
115
94
115
94mL
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, LEFT VENTRICLE

MRI


6VISIT 62023-04-06
-01
376
326
3
11DMD-EFCVDMD-EF-01-101
10
112-2
RVEF
LVEF_C
Right
Left Ventricular Ejection Fraction,
Calculated
Cal
66
65%
66
65
66
65%
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, LEFT VENTRICLEMRI
6VISIT 62023-04-06326
12DMD-EFCVDMD-EF-01
376
-101122-2CARDOUTCardiac Output4.0L/min4.04.0L/minHEART, LEFT VENTRICLE

MRI


6VISIT 62023-04-06326
13
4
DMD-EFCVDMD-EF-01-101
11
13
LVESV

ESV

Left Ventricle
End Systolic Volume
20
36mL
20
36
20
36mL
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, RIGHT VENTRICLE

MRI


6VISIT 62023-04-06
-01
376
326
5
14DMD-EFCVDMD-EF-01-101
12
14
LVEDV

EDV

Left Ventricle
End Diastolic Volume
100
93mL
100
93
100
93mL
HEART, RIGHT VENTRICLEMRI
CARDIAC MAGNETIC RESONANCE IMAGING

6VISIT 62023-04-06
-01
376
326
6
15DMD-EFCVDMD-EF-01-101
13
152-2
LVEF
RVEF_C
Left
Right Ventricular Ejection Fraction,
Calculated
Cal
50
70%
50
70
50
70%
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, RIGHT VENTRICLE

MRI


6VISIT 62023-04-06
-01
376
326
7
16DMD-EFCVDMD-EF-01-101
14
162-2
LVCO
CARDOUT
LV
Cardiac Output4.
5
0L/min4.
5
04.
5
0L/min
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, RIGHT VENTRICLE

MRI


6VISIT 62023-04-06
-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
Namelb
Rowcaps
Row 1:Shows the results for the N-Terminal ProB-type Natriuretic Peptide test for subject 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
RowSTUDYIDDOMAINUSUBJIDLBSEQLBLNKIDLBTESTCDLBTESTLBCATLBORRESLBORRESULBORNRLOLBORNRHILBSTRESCLBSTRESNLBSTRESULBSTNRLOLBSTRNHILBNRINDLBLOINCLBSPECLBLOBXFLVISITNUMVISITLBDTCLBDY
1DMD-EFLBDMD-EF-01-10112-1BNPPRONTN-Terminal ProB-type Natriuretic PeptideCHEMISTRY40pg/mL01004040IUng/L010040NORMAL 7142571425-3BLOOD
1SCREENINGVISIT 12022-05-161
2DMD-EFLBDMD-EF-01-10122-2BNPPRONTN-Terminal ProB-type Natriuretic PeptideCHEMISTRY900pg/mL0100900900IUng/L0100900HIGH71425-3BLOOD
6VISIT 62023-04-06-01376326

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
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serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-18
 
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
columnIdsissuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution
columnskey,summary,type,created,updated,due,assignee,reporter,priority,status,resolution
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-19

Dataset wrap
Namerelrec
Dataset2

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1DMD-EFCV
CVLNKID
MANY2
2DMD-EFLB
LBLNKID
ONE2