The Procedures (PR) domain contains interventional activity intended to have diagnostic, preventive, therapeutic, or palliative effects. This example PR dataset shows the CMR imaging with 2 different MRI machines. The sponsor device identifier (SPDEVID) variable is used to represent the imaging device identifier information provided in the DI dataset.
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Row 1: | Shows the procedure of a cardiac MRI for participant DMD-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. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | PRSEQ | SPDEVID | PRREFID | PRLNKID | PRTRT | PRLOC | PRFAST | PRSTDTC |
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| 1 | DMD-LGE | PR | DMD-LGE-01-201 | 1 | ABC001 | 12345678 | 04 | MRI | HEART | Y | 2023-07-01T09:15:00 | | 2 | DMD-LGE | PR | DMD-LGE-01-202 | 1 | ABC002 | 98765432 | 05 | MRI | HEART | N | 2023-07-05 |
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This 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.
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Row 1: | Shows that LGE is positive for participant DMD-LGE-01-201. | Row 2: | Shows the total LGE percentage is 40%. | Rows 3-19: | Show the segmental LGE results for each of the left ventricle segments. | Row 20: | Shows the LGE segment count. | Rows 21-24: | Show the segmental LGE percentage for each of the positive segments. | Row 25: | Shows that LGE is negative for participant DMD-LGE-01-202. |
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| Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVLOC | CVMETHOD | CVLOBFXL | CVANMETH | VISITNUM | VISIT | CVDTC |
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| 1 | DMD-LGE | CV | DMD-LGE-01-201 | 1 |
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| LATE GADOLINIUM ENHANCEMENT | CARDIAC MAGNETIC RESONANCE IMAGING | 04 | LGE | Late Gadolinium Enhancement | |
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| HEART, LEFT VENTRICLE | MRI |
| VISUAL | 1 |
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SCREENING| VISIT 1 | 2023-07-01 | | 2 | DMD-LGE | CV | DMD-LGE-01-201 | 2 |
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LATE GADOLINIUM ENHANCEMENT (# of segments) | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | 04 | LGEPER | Late Gadolinium Enhancement Percentage | | % | | 40 | % | HEART, LEFT VENTRICLE | MRI |
| QUANTITATIVE | 1 | VISIT 1 |
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SCREENING | 2023-07-01 | | 3 | DMD-LGE | CV | DMD-LGE-01-201 | 3 |
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LGEPER | | 04 | SGELGE | Segmental Late Gadolinium Enhancement | NEGATIVE |
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LATE GADOLINIUM ENHANCEMENT PERCENTAGE |
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| LEFT VENTRICULAR BASAL ANTERIOR SEGMENT |
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CARDIAC MAGNETIC RESONANCE IMAGINGSCREENING| VISIT 1 | 2023-07-01 | | 4 | DMD-LGE | CV | DMD-LGE-01-201 | 4 |
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LGEPER | | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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LATE GADOLINIUM ENHANCEMENT PERCENTAGE ANTEROSEPTAL CARDIAC MAGNETIC RESONANCE IMAGINGSCREENING| VISIT 1 | 2023-07-01 | | 5 | DMD-LGE | CV | DMD-LGE-01-201 | 5 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 6 | DMD-LGE | CV | DMD-LGE-01-201 | 6 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 7 | DMD-LGE | CV | DMD-LGE-01-201 | 7 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL INFEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 8 | DMD-LGE | CV | DMD-LGE-01-201 | 8 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 9 | DMD-LGE | CV | DMD-LGE-01-201 | 9 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID ANTERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 10 | DMD-LGE | CV | DMD-LGE-01-201 | 10 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 11 | DMD-LGE | CV | DMD-LGE-01-201 | 11 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 12 | DMD-LGE | CV | DMD-LGE-01-201 | 12 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID INFERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 13 | DMD-LGE | CV | DMD-LGE-01-201 | 13 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID INFEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 14 | DMD-LGE | CV | DMD-LGE-01-201 | 14 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID ANTEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 15 | DMD-LGE | CV | DMD-LGE-01-201 | 15 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APICAL ANTERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 16 | DMD-LGE | CV | DMD-LGE-01-201 | 16 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APICAL SEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 17 | DMD-LGE | CV | DMD-LGE-01-201 | 17 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APICAL INFERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 18 | DMD-LGE | CV | DMD-LGE-01-201 | 18 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APICAL LATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 19 | DMD-LGE | CV | DMD-LGE-01-201 | 19 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APEX SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 20 | DMD-LGE | CV | DMD-LGE-01-201 | 20 | 04 | LGESEGCT | Late Gadolinium Enhancement Segment Ct | |
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| HEART, LEFT VENTRICLE | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 21 | DMD-LGE | CV | DMD-LGE-01-201 | 21 | 04 | LGEPER | Late Gadolinium Enhancement Percentage | | % | | 40 | % | LEFT VENTRICULAR BASAL ANTEROLATERAL SEGMENT | MRI |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | | 22 | DMD-LGE | CV | DMD-LGE-01-201 | 22 | 04 | LGEPER |
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LATE GADOLINIUM ENHANCEMENT PERCENTAGE | LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-07-01 | Late Gadolinium Enhancement Percentage | | % | | 20 | % | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | MRI |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | | 23 | DMD-LGE | CV | DMD-LGE-01-201 | 23 | 04 | LGEPER | Late Gadolinium Enhancement Percentage | | % | | 45 | % | LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT | MRI |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | | 24 | DMD-LGE | CV | DMD-LGE-01-201 | 24 | 04 | LGEPER | Late Gadolinium Enhancement Percentage | | % | | 20 | % | LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT | MRI |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | | 25 | DMD-LGE | CV | DMD-LGE-01-202 | 1 | 05 | LGE | Late Gadolinium Enhancement | |
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| HEART, LEFT VENTRICLE | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-05 |
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The Procedure Agents (AG) domain contains the agents administered to the subject as part of a procedure or assessment. This example AG dataset shows the timing of the gadolinium-based contrast, Gd-DOTA. The time the contrast was given to participant DMD-LGE-01-202 was not available, so only the date is represented in AGSTDTC variable.
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Row | STUDYID | DOMAIN | USUBJID | AGSEQ | AGLNKID | AGTRT | AGCAT | AGDOSE | AGDOSU | AGDOSFRM | AGROUTE | VISITNUM | AGSTDTC |
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1 | DMD-LGE | AG | DMD-LGE-01-201 | 1 | 04 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | VISIT 1 | 2023-07-01T09:25:00 | 2 | DMD-LGE | AG | DMD-LGE-01-202 | 2 | 05 | Gd-DOTA | CONTRAST AGENT | 10 | mL | SOLUTION | INTRAVENOUS | VISIT 1 | 2023-07-05 |
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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.
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Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
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1 | DMD-LGE | DI | ABC001 | 1 | DEVTYPE | Device Type | CMR Scanner | 2 | DMD-LGE | DI | ABC002 | 1 | DEVTYPE | Device Type | CMR Scanner |
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The RELREC dataset is used to describe the relationship between 2 or more records in different domains.
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | DMD-LGE | PR |
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| ONE | 04 | 2 | DMD-LGE | CV |
| CVLNKID |
| MANY | 04 | 3 | DMD-LGE | AG |
| AGLNKID |
| ONE | 04 |
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