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Comment: In the PR domain, changed "results" to "procedure" since the PR domain is showing the procedure and not the results... typo?

This example dataset shows the findings associated with a cardiac magnetic resonance imaging procedure related to late gadolinium enhancement.

The Procedures (PR) domain represents contains interventional activity intended to have diagnostic, preventive, and therapeutic activity. The , or palliative effects. This example PR dataset shows the cardiac magnetic resonance CMR imaging with two 2 different MRI machines, using the SPDEVID . The sponsor device identifier (SPDEVID) variable is used to represent the imaging device identifier information provided in the DI dataset below.The ANMETH variable describes the analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result (e.g., an image, a genetic sequence) which in this case applies to the CMR imaging.

TO DO - Describe the analysis method for LGE - three different methods:

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Dataset wrap
Namepr
Rowcaps

Row 1:

Shows the procedure of a cardiac MRI for participant 101DMD-LGE-01-201.

Row 2:

Shows the procedure of a cardiac MRI for participant DMD-LGE-01-202 with a different MRI machine. The time of the procedure was not available, so only the date is shown in the PRSTDTC variable.

Dataset2
Row

STUDYID

DOMAIN

USUBJID

PRSEQ

SPDEVID

PRSEQ

PRREFID

PRLNKID

PRTRT

PRLOC

PRFAST

PRSTDTC

1

DMD-EFLGELGE

PR

DMD-LGE-01-201

1

101

ABC0011

12345678

04

MRI

HEARTCARDIAC MAGNETIC RESONANCE IMAGING

Y

2023-07-01T09:15:00

2

DMD-EFLGELGE

PR

DMD-LGE-01-202

1

ABC0021

98765432

05

MRIHEARTCARDIAC MAGNETIC RESONANCE IMAGING

N

2023-07-05

The Cardiovascular System Findings (CV) dataset contains physiological and morphological findings related to the cardiovascular system, including the heart, blood vessels and lymphatic vessels. The findings from the CMR procedure for LGE are noted in this example. If LGE was not performed, it would not appear in the datasetThis example CV dataset shows the results of the LGE test measured using CMR imaging. The analysis method describes the method of secondary processing applied to a complex observation result (e.g., an image, a genetic sequence). There may be machine-centric analysis methods inherit to the type of machine (e.g., full-width half maximum, 5 standard deviations, 6 standard deviations).[7] If this information is of interest to the study, it would be represented using the CVANMETH variable.

Dataset wrap
Namecv
Rowcaps

Row 1:

Shows the late gadolinium enhancement (that LGE ) is positive for the overall Left Ventricle for participant 101DMD-LGE-01-201.

Row 2:

Shows the late gadolinium enhancement (LGE) overall Left Ventricle total LGE percentage is 40% for participant 101.

Rows 3-1819:

Show the segmental late gadolinium enhancement (LGE) values LGE results for each of the left ventricle segments for participant 101.

Row 1920:

Shows the total late gadolinium enhancement (LGE) positive segments for participant 101LGE segment count.

Rows 2021-2324:

Show the segmental late gadolinium enhancement ( LGE ) percentage for each of the positive LGE segments for participant 101

Row 2425:

Shows the late gadolinium enhancement (that LGE ) is negative for participant DMD-LGE-01-202.

Dataset2
Row

STUDYID

DOMAIN

USUBJID

CVSEQ

CVLNKID

CVTESTCD

CVTEST

CVORRES

CVORRESU

CVSTRESC

CVSTRESN

CVSTRESU

CVLOC

CVMETHOD

CVLOBFXL

CVANMETH

VISITNUM

VISIT

CVDTC

1DMD-EFLGELGECV101DMD-LGE-01-201104LGELATE GADOLINIUM ENHANCEMENTLate Gadolinium Enhancement

POSITIVE


POSITIVE



HEART, LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
2DMD-EFLGELGECV101DMD-LGE-01-201204TLGEPRLGEPERLate Gadolinium Enhancement PercentageTOTAL LATE GADOLINIUM ENHANCEMENT PERCENTAGE

40

%

40

40%HEART, LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGINGMRI
QUANTITATIVE1VISIT 12023-07-01
3DMD-EFLGELGECV101DMD-LGE-01-201304SGTLGESGELGE

Segmental Late Gadolinium Enhancement

SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE

NEGATIVE



LEFT VENTRICULAR BASAL ANTERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
4DMD-EFLGELGECV101DMD-LGE-01-201404SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICULAR BASAL ANTEROSEPTAL ANTEROLATERAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
5DMD-EFLGELGECV101DMD-LGE-01-201504SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICULAR BASAL

INFEROSEPTAL

ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
6DMD-EFLGELGECV101DMD-LGE-01-201604SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFERIOR SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
7DMD-EFLGELGECV101DMD-LGE-01-201704SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFEROLATERAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
8DMD-EFLGELGECV101DMD-LGE-01-201804SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR ANTEROLATERAL BASAL INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
9DMD-EFLGELGECV101DMD-LGE-01-201904SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID ANTERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
10DMD-EFLGELGECV101DMD-LGE-01-2011004SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
11DMD-EFLGELGECV101DMD-LGE-01-2011104SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICULAR MID INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
12DMD-EFLGELGECV101DMD-LGE-01-2011204SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
13DMD-EFLGELGECV101DMD-LGE-01-2011304SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID INFEROLATERAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
14DMD-EFLGELGECV101DMD-LGE-01-2011404SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID ANTEROLATERAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
15DMD-EFLGELGECV101DMD-LGE-01-2011504SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL ANTERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
16DMD-EFLGELGECV101DMD-LGE-01-2011604SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL SEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
17DMD-EFLGELGECV101DMD-LGE-01-2011704SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
18DMD-EFLGELGECV101DMD-LGE-01-2011804SGTLGESGELGESegmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL LATERAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
19DMD-EFLGELGECV101DMD-LGE-01-2011904SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APEX SEGMENTMRI
VISUAL1VISIT 12023-07-01
20DMD-LGECVDMD-LGE-01-2012004

LGESEGCT

Late Gadolinium Enhancement Segment Ct

TLGETOTAL LGE SEGMENTS

4


4

4
HEART, LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
2021DMD-EFLGELGECV101DMD-LGE-01-201212004LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGELate Gadolinium Enhancement Percentage

40

%

40

40%LEFT VENTRICULAR BASAL ANTEROSEPTAL ANTEROLATERAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
2122DMD-EFLGELGECV101DMD-LGE-01-201222104LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGELate Gadolinium Enhancement Percentage

20

%

20

20%LEFT VENTRICULAR BASAL INFEROSEPTAL ANTEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
2223DMD-EFLGELGECV101DMD-LGE-01-201232204LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGELate Gadolinium Enhancement Percentage

45

%

45

45%LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
2324DMD-EFLGELGECV101DMD-LGE-01-201242304LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGELate Gadolinium Enhancement Percentage

20

%

20

20%LEFT VENTRICULAR MID INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
2425DMD-EFLGELGECVDMD-LGE-01-20210405LGELATE GADOLINIUM ENHANCEMENTLate Gadolinium Enhancement

NEGATIVE


NEGATIVE



HEART, LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-05

The Procedure Agent Agents (AG) dataset is an interventions domain that contains the agents administered to the participant subject as part of a procedure or assessment. The This example AG dataset shows the timing of the Gadolinium gadolinium-based contrast, GDGd-DOTA.   Participant 202 did not have the The time the contrast was given to participant DMD-LGE-01-202 was not available, so only the date is represented in AGSTDTC variable.

Dataset wrap
Nameag
Dataset2

Row

STUDYID

DOMAIN

USUBJID

AGSEQ

AGLNKID

AGTRT

AGCAT

AGDOSE

AGDOSU

AGDOSFRM

AGROUTE

VISITNUM

AGSTDTC

1

DMD-EFLGELGE

AG101

DMD-LGE-01-201

1

04

Gd-DOTA

CONTRAST AGENT

8

mL

SOLUTION

INTRAVENOUS

VISIT 1

2023-07-01T09:25:00

2

DMD-EFLGELGE

AG

DMD-LGE-01-202

2

0405

Gd-DOTA

CONTRAST AGENT

10

mL

SOLUTION

INTRAVENOUS

VISIT 1

2023-07-05

The Device Identifiers (DI) domain is used to represent the device information details. For this particular example, the device type was the only detail of interest to the researchers. The sequence number (DISEQ) is specific to each device; note there are 2 different CMR scanners noted with different values in the SPDEVID variable. Each scanner has a value of "1" for the DISEQ variable since there is only 1 record or row for each device.

Dataset wrap
Namedi
Dataset2

Row

STUDYID

DOMAIN

SPDEVID

DISEQ

DIPARMCD

DIPARM

DIVAL

1

DMD-LGE

DI

ABC001

1

DEVTYPE

Device Type

CMR Scanner

2

DMD-LGE

DI

ABC002

1

DEVTYPE

Device Type

CMR Scanner

The RELREC dataset is used to describe the relationship between 2 or more records in different domains.

Dataset wrap
Namerelrec
Dataset2

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1

DMD-LGE

PR


PRLNKID


ONE

04

2

DMD-LGE

CV


CVLNKID


MANY

04

3

DMD-LGE

AG


AGLNKID


ONE

04