The procedures Procedures (PR) domain contains interventional activity intended to have diagnostic, preventive, therapeutic, or palliative effects. The This example PR dataset below shows the cardiac magnetic resonance CMR imaging with two 2 different MRI machines (PRTRT=MRI and PRLOC=HEART). The sponsor device identifier (SPDEVID) variable variable is used to represent the imaging device identifier information provided in the DI dataset below.
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Row 1: | Shows the results procedure of a cardiac MRI for participant DMD-LGE-01-201. | Row 2: | Shows the results 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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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | SPDEVID | PRREFID | PRLNKID | PRTRT | PRLOC | PRFAST | PRSTDTC |
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1 | DMD-EFLGELGE | PR | DMD-LGE-01-201 | 1 | ABC001 | 12345678 | 04 | MRI | HEART | Y | 2023-07-01T09:15:00 | 2 | DMD-EFLGELGE | PR | DMD-LGE-01-202 | 1 | ABC002 | 98765432 | 05 | MRI | HEART | N | 2023-07-05 |
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The This example CV dataset below 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). (Ref: https://jcmr-online.biomedcentral.com/articles/10.1186/1532-429X-12-21). If [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-EFLGELGE | CV | DMD-LGE-01-201 | 1 | 04 | LGELATE GADOLINIUM ENHANCEMENT | Late Gadolinium Enhancement | |
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| HEART, LEFT VENTRICLE | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 2 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 2 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 40 | % | HEART, LEFT VENTRICLE | MRI |
| QUANTITATIVE | 1 | VISIT 1 | 2023-07-01 | 3 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 3 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | NEGATIVE |
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| LEFT VENTRICULAR BASAL ANTERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 4 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 4 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL ANTEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 5 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 5 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 6 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 6 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 7 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 7 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL INFEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 8 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 8 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 9 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 9 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID ANTERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 10 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 10 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 11 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 11 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 12 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 12 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID INFERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 13 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 13 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID INFEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 14 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 14 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID ANTEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 15 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 15 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APICAL ANTERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 16 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 16 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APICAL SEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 17 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 17 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APICAL INFERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 18 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 18 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APICAL LATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 19 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 19 | 04 | SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APEX SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 20 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 20 | 04 | LGESEGCT LATE GADOLINIUM ENHANCEMENT SEGMENT CT | Late Gadolinium Enhancement Segment Ct | |
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| HEART, LEFT VENTRICLE | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 21 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 21 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 40 | % | LEFT VENTRICULAR BASAL ANTEROSEPTAL ANTEROLATERAL SEGMENT | MRI |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | 22 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 22 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 20 | % | LEFT VENTRICULAR BASAL INFEROSEPTAL ANTEROSEPTAL SEGMENT | MRI |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | 23 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 23 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 45 | % | LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT | MRI |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | 24 | DMD-EFLGELGE | CV | DMD-LGE-01-201 | 24 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 20 | % | LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT | MRI |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | 25 | DMD-EFLGELGE | CV | DMD-LGE-01-202 | 1 | 05 | LGELATE GADOLINIUM ENHANCEMENT | 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 Procedure Agents (AG) domain contains the agents administered to the subject as part of a procedure or assessment. The This example AG dataset below 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-EFLGELGE | AG | 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 |
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The device identifiers 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 two 2 different CMR scanners noted with different values in the SPDEVID variable. Each scanners scanner has a value of "1" for the DISEQ variable since there is only one 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-EFLGELGE | DI | ABC001 | 1 | DEVTYPE | Device Type | CMR Scanner | 2 | DMD-EFLGELGE | 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 |
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| ONE | 04 |
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