Versions Compared

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 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
Namecv
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
tableidcv
RowSTUDYIDDOMAINUSUBJIDCVSEQCVLNKIDCVTESTCDCVTESTCVORRESCVORRESUCVSTRESCCVSTRESNCVSTRESUCVLOCCVMETHODCVLOBXFLVISITNUMVISITCVDTCCVDY
1DMD-EFCVDMD-EF-01-1011
LVESV

ESV

Left Ventricle
End Systolic Volume32mL3232mL
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, LEFT VENTRICLEMRI
1
SCREENING
VISIT 12022-05-161
2DMD-EFCVDMD-EF-01-1012
LVEDV

EDV

Left Ventricle
End Diastolic Volume95mL9595mL
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, LEFT VENTRICLE

MRI


1
SCREENING
VISIT 12022-05-161
3DMD-EFCVDMD-EF-01-10132-1LVEF_CLeft Ventricular Ejection Fraction,
Calculated
Cal
67
70%
67
70
67
70%
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, LEFT VENTRICLEMRI
1
SCREENING
VISIT 12022-05-161
4DMD-EFCVDMD-EF-01-10142-1
LVCO
CARDOUT
LV
Cardiac Output5.4L/min5.45.4L/min
HEART, LEFT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING


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

ESV

Right Ventricle
End Systolic Volume24mL2424mL
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, RIGHT VENTRICLE

MRI


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

EDV

Right Ventricle
End Diastolic Volume90mL9090mL
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, RIGHT VENTRICLEMRI
1
SCREENING
VISIT 12022-05-161
7DMD-EFCVDMD-EF-01-10172-1RVEF_CRight Ventricular Ejection Fraction,
Calculated
Cal
74
75%
74
75
74
75%
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, RIGHT VENTRICLE

MRI


1
SCREENING
VISIT 12022-05-161
8DMD-EFCVDMD-EF-01-10182-1
RVCO
CARDOUT
RV
Cardiac Output5.6L/min5.65.6L/min
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, RIGHT VENTRICLE

MRI


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

ESV

Left Ventricle
End Systolic Volume37mL3737mL
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, LEFT VENTRICLEMRI
6VISIT 62023-04-06
-01
376
326
10DMD-EFCVDMD-EF-01-10110
LVEDV

EDV

Left Ventricle
End Diastolic Volume94mL9494mL
HEART, LEFT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING


6VISIT 62023-04-06
-01
376
326
11DMD-EFCVDMD-EF-01-101112-2LVEF_CLeft Ventricular Ejection Fraction,
Calculated
Cal
60
65%
60
65
60
65%
HEART, LEFT VENTRICLEMRI
CARDIAC MAGNETIC RESONANCE IMAGING

6VISIT 62023-04-06
-01
376
326
12DMD-EFCVDMD-EF-01-101122-2
LVCO
CARDOUT
LV
Cardiac Output4.0L/min4.04.0L/min
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, LEFT VENTRICLE

MRI


6VISIT 62023-04-06
-01
376
326
13DMD-EFCVDMD-EF-01-10113
RVESV

ESV

Right Ventricle
End Systolic Volume36mL3636mL
HEART, RIGHT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING


6VISIT 62023-04-06
-01
376
326
14DMD-EFCVDMD-EF-01-10114
RVEDV

EDV

Right Ventricle
End Diastolic Volume93mL9393mL
CARDIAC MAGNETIC RESONANCE IMAGING
HEART, RIGHT VENTRICLEMRI
6VISIT 62023-04-06
-01
376
326
15DMD-EFCVDMD-EF-01-101152-2RVEF_CRight Ventricular Ejection Fraction,
Calculated
Cal
61
70%
61
70
61
70%
HEART, RIGHT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING


6VISIT 62023-04-06
-01
376
326
16DMD-EFCVDMD-EF-01-101162-2
RVCO
CARDOUT
RV
Cardiac Output4.0L/min4.04.0L/min
HEART, RIGHT VENTRICLE

MRI

CARDIAC MAGNETIC RESONANCE IMAGING


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 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
RowSTUDYIDDOMAINUSUBJIDLBSEQLBLNKIDLBTESTCDLBTESTLBCATLBORRESLBORRESULBORNRLOLBORNRHILBSTRESCLBSTRESNLBSTRESULBSTNRLOLBSTRNHILBNRINDLBLOINCLBSPECLBLOBXFLVISITNUMVISITLBDTCLBDY
1DMD-EFLBDMD-EF-01-10112-1BNPPRONTN-Terminal ProB-type Natriuretic PeptideCHEMISTRY40pg/mL01004040IUng/L010040NORMAL71425-3BLOOD
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
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