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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

dm.xpt

RowSTUDYIDDOMAINUSUBJIDSUBJIDRFSTDTCRFENDTCRFXSTDTCRFXENDTCRFICDTCRFPENDTCDTHDTCDTHFLSITEIDBRTHDTCAGEAGEUSEXRACEARMCDARMACTARMCDACTARMARMNRSACTARMUDCOUNTRY
1DMD-EFDMDMD-EF-01-1011012021-02-15T09:00






012013-02-078YEARSM
ADrug AADrug A


2DMD-EFDMDMD-EF-01-1021022021-01-13T08:00






012006-05-0114YEARSM
ADrug AADrug A


3DMD-EFDMDMD-EF-01-1031032021-04-15T10:15






012001-07-1019YEARSM
BDrug BBDrug B


4DMD-EFDMDMD-EF-01-1041042021-05-06T09:30






011999-01-1522YEARSM
BDrug BBDrug B


$warningHtml

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

vs.xpt

RowSTUDYIDDOMAINUSUBJIDVSSEQVSTESTCDVSTESTVSORRESVSORRESUVSSTRESCVSSTRESNVSSTRESUVSLOBFXLVISITNUMVISITVSDTC
1DMD-EFVSDMD-EF-01-1011HEIGHTHeight47in119119cm
1VISIT 12022-05-16
2DMD-EFVSDMD-EF-01-1012WEIGHTWeight20kg2020kg
1VISIT 12022-05-16
3DMD-EFVSDMD-EF-01-1013HEIGHTHeight52in132132cm
6VISIT 62023-04-06
4DMD-EFVSDMD-EF-01-1014WEIGHTWeight32kg3232kg
6VISIT 62023-04-06
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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

cv.xpt

RowSTUDYIDDOMAINUSUBJIDCVSEQCVLNKIDCVTESTCDCVTESTCVORRESCVORRESUCVSTRESCCVSTRESNCVSTRESUCVLOCCVMETHODCVLOBXFLVISITNUMVISITCVDTCCVDY
1DMD-EFCVDMD-EF-01-1011

ESV

End Systolic Volume32mL3232mLHEART, LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 12022-05-161
2DMD-EFCVDMD-EF-01-1012

EDV

End Diastolic Volume95mL9595mLHEART, LEFT VENTRICLE

CARDIAC MAGNETIC RESONANCE IMAGING


1VISIT 12022-05-161
3DMD-EFCVDMD-EF-01-10132LVEF_CLeft Ventricular Ejection Fraction, Calculated67%6767%HEART, LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 12022-05-161
4DMD-EFCVDMD-EF-01-10142CARDOUTCardiac Output5.4L/min5.45.4L/minHEART, LEFT VENTRICLE

CARDIAC MAGNETIC RESONANCE IMAGING


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

ESV

End Systolic Volume24mL2424mLHEART, RIGHT VENTRICLE

CARDIAC MAGNETIC RESONANCE IMAGING


1VISIT 12022-05-161
6DMD-EFCVDMD-EF-01-1016

EDV

End Diastolic Volume90mL9090mLHEART, RIGHT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 12022-05-161
7DMD-EFCVDMD-EF-01-10172RVEF_CRight Ventricular Ejection Fraction, Calculated74%7474%HEART, RIGHT VENTRICLE

CARDIAC MAGNETIC RESONANCE IMAGING


1VISIT 12022-05-161
8DMD-EFCVDMD-EF-01-10182CARDOUTCardiac Output5.6L/min5.65.6L/minHEART, RIGHT VENTRICLE

CARDIAC MAGNETIC RESONANCE IMAGING


1VISIT 12022-05-161
9DMD-EFCVDMD-EF-01-1019

ESV

End Systolic Volume37mL3737mLHEART, LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGING
6VISIT 62023-04-06325
10DMD-EFCVDMD-EF-01-10110

EDV

End Diastolic Volume94mL9494mLHEART, LEFT VENTRICLE

CARDIAC MAGNETIC RESONANCE IMAGING


6VISIT 62023-04-06325
11DMD-EFCVDMD-EF-01-101112LVEF_CLeft Ventricular Ejection Fraction, Calculated60%6060%HEART, LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGING
6VISIT 62023-04-06325
12DMD-EFCVDMD-EF-01-101122CARDOUTCardiac Output4.0L/min4.04.0L/minHEART, LEFT VENTRICLE

CARDIAC MAGNETIC RESONANCE IMAGING


6VISIT 62023-04-06325
13DMD-EFCVDMD-EF-01-10113

ESV

End Systolic Volume36mL3636mLHEART, RIGHT VENTRICLE

CARDIAC MAGNETIC RESONANCE IMAGING


6VISIT 62023-04-06325
14DMD-EFCVDMD-EF-01-10114

EDV

End Diastolic Volume93mL9393mLHEART, RIGHT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGING
6VISIT 62023-04-06325
15DMD-EFCVDMD-EF-01-101152RVEF_CRight Ventricular Ejection Fraction, Calculated61%6161%HEART, RIGHT VENTRICLE

CARDIAC MAGNETIC RESONANCE IMAGING


6VISIT 62023-04-06325
16DMD-EFCVDMD-EF-01-101162CARDOUTCardiac Output4.0L/min4.04.0L/minHEART, RIGHT VENTRICLE

CARDIAC MAGNETIC RESONANCE IMAGING


6VISIT 62023-04-06325
$warningHtml

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

lb.xpt

RowSTUDYIDDOMAINUSUBJIDLBSEQLBLNKIDLBTESTCDLBTESTLBCATLBORRESLBORRESULBORNRLOLBORNRHILBSTRESCLBSTRESNLBSTRESULBSTNRLOLBSTRNHILBNRINDLBLOINCLBSPECLBLOBXFLVISITNUMVISITLBDTCLBDY
1DMD-EFLBDMD-EF-01-10112BNPPRONTN-Terminal ProB-type Natriuretic PeptideCHEMISTRY40pg/mL01004040IU/L10040NORMAL71425-3BLOOD
1VISIT 12022-05-161
2DMD-EFLBDMD-EF-01-10122BNPPRONTN-Terminal ProB-type Natriuretic PeptideCHEMISTRY900pg/mL0100900900IU/L100900HIGH71425-3BLOOD
6VISIT 62023-04-06325
$warningHtml

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

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