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Does this need to be LVEDV? It is currently LVDV. The CVTESTCD have "E", should the CVTEST have "End" in the term?
Ejection Fraction - Liters/minutes or percentage? |
This 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.
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| Rows 1-8: | Show the baseline CMR ejection fraction measurements for participant 101 at Screening. | | Rows 9-16: | Show the CMR ejection fraction measurements for participant 101 at VISIT 6. |
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| Dataset2 |
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| | Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVMETHOD | VISITNUM | VISIT | CVDTC | CVDY |
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| 1 | DMD-EF | CV | 101 | 1 |
| RVESV | Right Ventricle Systolic Volume | 23.5 | mL | 23.5 | 23.5 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 |
| | 2 | DMD-EF | CV | 101 | 2 |
| RVEDV | Right Ventricle Diastolic Volume | 89.7 | mL | 89.7 | 89.7 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 |
| | 3 | DMD-EF | CV | 101 | 3 | 2 | RVEF_C | Right Ventricular Ejection Fraction, Calculated | 73.8 | % | 73.8 | 73.8 | % | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 |
| | 4 | DMD-EF | CV | 101 | 4 | 2 | RVCO | RV Cardiac Output | 5.6 | L/min | 5.6 | 5.6 | L/min | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 |
| | 5 | DMD-EF | CV | 101 | 5 |
| LVESV | Left Ventricle Systolic Volume | 31.7 | mL | 31.7 | 31.7 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 |
| | 6 | DMD-EF | CV | 101 | 6 |
| LVEDV | Left Ventricle Diastolic Volume | 94.8 | mL | 94.8 | 94.8 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 |
| | 7 | DMD-EF | CV | 101 | 7 | 2 | LVEF_C | Left Ventricular Ejection Fraction, Calculated | 66.5 | % | 66.5 | 66.5 | % | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 |
| | 8 | DMD-EF | CV | 101 | 8 | 2 | LVCO | LV Cardiac Output | 5.4 | L/min | 5.4 | 5.4 | L/min | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 |
| | 9 | DMD-EF | CV | 101 | 9 |
| RVESV | Right Ventricle Systolic Volume | 35.9 | mL | 35.9 | 35.9 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 | | 10 | DMD-EF | CV | 101 | 10 |
| RVEDV | Right Ventricle Diastolic Volume | 92.8 | mL | 92.8 | 92.8 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 | | 11 | DMD-EF | CV | 101 | 11 | 2 | RVEF_C | Right Ventricular Ejection Fraction, Calculated | 61.3 | % | 61.3 | 61.3 | % | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 | | 12 | DMD-EF | CV | 101 | 12 | 2 | RVCO | RV Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 | | 13 | DMD-EF | CV | 101 | 13 |
| LVESV | Left Ventricle Systolic Volume | 37.4 | mL | 37.4 | 37.4 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 | | 14 | DMD-EF | CV | 101 | 14 |
| LVEDV | Left Ventricle Diastolic Volume | 93.8 | mL | 93.8 | 93.8 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 | | 15 | DMD-EF | CV | 101 | 15 | 2 | LVEF_C | Left Ventricular Ejection Fraction, Calculated | 60 | % | 60 | 60 | % | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 | | 16 | DMD-EF | CV | 101 | 16 | 2 | LVCO | LV Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 |
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| Row 1: | Shows the results for the N-Terminal ProB-type Natriuretic Peptide test for participant 101 at Screening. | | Row 2: | Shows the results for the N-Terminal ProB-type Natriuretic Peptide test at Visit 6. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBLNKID | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBORNRLO | LBORNRHI | LBSTRESC | LBSTRESN | LBSTRESU | LBSTNRLO | LBSTRNHI | LBNRIND | LBLOINC | LBSPEC | VISITNUM | VISIT | LBDTC | LBDY | | 1 | DMD-EF | LB | 101 | 1 | 2 | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide | CHEMISTRY | 40 | pg/mL | 0 | 100 | 40 | 40 | IU/L | 100 | 40 | NORMAL | 71425-3 | BLOOD | 1 | SCREENING | 2022-05-16 |
| | 2 | DMD-EF | LB | 101 | 2 | 2 | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide | CHEMISTRY | 900 | pg/mL | 0 | 100 | 900 | 900 | IU/L | 100 | 900 | HIGH | 71425-3 | BLOOD | 6 | VISIT 6 | 2023-06-01 | 376 |
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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.
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| Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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| 1 | DMD-EF | CV |
| CVLNKID |
| MANY | 2 | | 2 | DMD-EF | LB |
| LBLNKID |
| ONE | 2 |
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