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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
Info
titleNotes
  • CVORRES: Result of the measurement or finding as originally received or collected.
  • CVORRESU: Original units in which the data were collected. Unit for CVORRES.
  • CVSTRESC: Result value for all findings from CVORRES in a standard format or in standard units. If results are numeric, they should also be stored in numeric format in CVSTRESN.
  • CVSTRESN: Used for continuous or numeric results or findings in standard format; copied in numeric format from CVSTRESC.
  • CVSTRESU: Standardized units used for CVSTRESC and CVSTRESN.

Questions for the team:

  1. Include RV Cardiac Output and RV Cardiac Index measurements?
  2. Would there be a baseline at diagnosis of DMD and then a regular follow-up? How often would this occur?
  3. What would the anticipated abnormalities be on follow-up CMR?
  4. Do the CMR images have any cardiac labs done at the same time that would need to be linked (such as a BNP)?

The following example shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to ejection fraction.

Dataset2
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-EFCV
100
DMD-EF-01-1011
RVSYSVOL

ESV

Right Ventricle
End Systolic Volume
38
32mL
/m2
38
32
38
32mL
/m2CARDIAC MAGNETIC RESONANCE IMAGING
HEART, LEFT VENTRICLEMRI
1
SCREENING
VISIT 1
2023
2022-
06
05-
01
161
2DMD-EFCV
100
DMD-EF-01-1012
RVDIAVOL

EDV

Right Ventricle
End Diastolic Volume
8
95mL
/m2
8
95
8
95mL
/m2
HEART, LEFT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING


1
SCREENING
VISIT 1
2023
2022-
06
05-
01
161
3DMD-EFCV
100
DMD-EF-01-1013
RVEF
2-1LVEF_C
Right
Left Ventricular Ejection Fraction,
Calculated
Cal
38
70%
38
70
38		4
70%

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2023-06-01
HEART, LEFT VENTRICLEMRI
1VISIT 12022-05-161
4DMD-EFCVDMD-EF-01-10142-1CARDOUTCardiac Output5.4L/min5.45.4L/minHEART, LEFT VENTRICLE

MRI


1VISIT 12022-05-161
5
DMD-EFCV
1004LVSYSVOL
DMD-EF-01-1015

ESV

End
Left Ventricle
Systolic Volume
100
24mL
/m2
100
24
100
24mL
/m2
HEART, RIGHT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING


1
SCREENING
VISIT 1
2023
2022-
06
05-
01
161
5
6DMD-EFCV
1005LVDIAVOLLeft Ventricle Diastolic Volume60mL/m26060mL/m2

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2023-06-016DMD-EFCV100
DMD-EF-01-1016

EDV

End Diastolic Volume90mL9090mLHEART, RIGHT VENTRICLEMRI
1VISIT 12022-05-161
7DMD-EFCVDMD-EF-01-10172-1RVEF_CRight Ventricular Ejection Fraction, Cal75%7575%HEART, RIGHT VENTRICLE

MRI


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

MRI


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

ESV

End Systolic Volume37mL3737mLHEART, LEFT VENTRICLEMRI
6VISIT 62023-04-06326
10DMD-EFCVDMD-EF-01-10110

EDV

End Diastolic Volume94mL9494mLHEART, LEFT VENTRICLE

MRI


6VISIT 62023-04-06326
11DMD-EFCVDMD-EF-01-101112-2
6
LVEF_CLeft Ventricular Ejection Fraction,
Calculated
Cal
50
65%
50
65
50
65%
CARDIAC MAGNETIC RESONANCE IMAGING1
HEART, LEFT VENTRICLEMRI
6VISIT 6
SCREENING
2023-04-06
-01
326
7LV
12DMD-EFCV
1007LVCO
DMD-EF-01-101122-2CARDOUT
Cardiac Output4.
5
0L/min4.
5
04.
5
0L/min

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2023-06-01
HEART, LEFT VENTRICLE

MRI


6VISIT 62023-04-06326
13DMD-EFCVDMD-EF-01-10113

ESV

End Systolic Volume36mL3636mLHEART, RIGHT VENTRICLE

MRI


6VISIT 62023-04-06326
14DMD-EFCVDMD-EF-01-10114

EDV

End Diastolic Volume93mL9393mLHEART, RIGHT VENTRICLEMRI
6VISIT 62023-04-06326
15DMD-EFCVDMD-EF-01-101152-2RVEF_CRight Ventricular Ejection Fraction, Cal70%7070%HEART, RIGHT VENTRICLE

MRI


6VISIT 62023-04-06326
16
8
DMD-EFCV
1008LVCILV Cardiac Index
DMD-EF-01-101162-2CARDOUTCardiac Output4.0
3.6
L/min
/m23.63.6L/min/m2CARDIAC MAGNETIC RESONANCE IMAGING1SCREENING2023-06-01
4.04.0L/minHEART, RIGHT VENTRICLE

MRI


6VISIT 62023-04-06326

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 NT-proBNP test at visit 1.
Row 2:Shows the results for the NT-proBNP test at visit 6.
Dataset2
RowSTUDYIDDOMAINUSUBJIDLBSEQLBLNKIDLBTESTCDLBTESTLBCATLBORRESLBORRESULBORNRLOLBORNRHILBSTRESCLBSTRESNLBSTRESULBSTNRLOLBSTRNHILBNRINDLBLOINCLBSPECLBLOBXFLVISITNUMVISITLBDTCLBDY
1DMD-EFLBDMD-EF-01-10112-1BNPPRONTN-Terminal ProB-type Natriuretic PeptideCHEMISTRY40pg/mL01004040ng/L0100NORMAL71425-3BLOOD
1VISIT 12022-05-161
2DMD-EFLBDMD-EF-01-10122-2BNPPRONTN-Terminal ProB-type Natriuretic PeptideCHEMISTRY900pg/mL0100900900ng/L0100HIGH71425-3BLOOD
6VISIT 62023-04-06326

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

Jira
showSummaryfalse
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