Versions Compared

Old Version 24

changes.mady.by.user Alana St. Clair

Saved on

compared with

New Version Current

changes.mady.by.user Rebecca Baker

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

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.
Row 8:
Dataset2
tableidcv
Rowcaps
Row 1:Row 2:Row 3:Row 4:Row 5:Row 6:Row 7:
RowSTUDYIDDOMAINUSUBJIDCVSEQCVLNKIDCVTESTCDCVTESTCVORRESCVORRESUCVSTRESCCVSTRESNCVSTRESUCVLOCCVMETHODCVLOBXFLVISITNUMVISITCVDTCCVDY
1DMD-EFCVDMD-EF-01-1011
RVSYSVOL 1

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-EFCVDMD-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-EFCVDMD-EF-01-10132-1
RVEF
LVEF_C
Right
Left Ventricular Ejection Fraction,
Calculated
Cal
38
70%
38
70
38
70%

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2023-06-014
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-EFCVDMD-EF-01-101
4
5
LVSYSVOL

ESV

Left Ventricle
End 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-EFCVDMD-EF-01-101
5
6
LVDIAVOL

EDV

Left Ventricle
End Diastolic Volume
60mL/m26060mL/m2

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2023-06-01
90mL9090mLHEART, 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
11
6
DMD-EFCVDMD-EF-01-10111
6
2-2LVEF_CLeft Ventricular Ejection Fraction,
Calculated
Cal
50
65%
50
65
50
65%
CARDIAC MAGNETIC RESONANCE IMAGING1SCREENING2023-06-01
HEART, LEFT VENTRICLEMRI
6VISIT 62023-04-06326
12
7
DMD-EFCVDMD-EF-01-10112
7
2-2
LVCO
CARDOUT
LV
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-EFCVDMD-EF-01-10116
8
2-2
LVCI
CARDOUT
LV
Cardiac
Index
Output
3
4.
6
0L/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