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- Percent change in ejection fraction over time (1 year)
- Decline in ejection fraction over time (1 year) grouped by a decline greater than 5%
- Percent change in NT-proBNP over time (1 year)
Source Data
The SDTM examples used as the source data are from Section 2.1, Basic Systolic Function. The ADSL draws from the DM dataset. The CV dataset shows two visits for subject DMD-EF-01-101. The records for which CVTESTCD = "LVEF_C" and "RVEF_C" were selected for analysis. The records in the LB dataset where LBTESTCD = "BNPPRONT" were used to compute the percent change over time and as a potential covariate.
Example Analysis Datasets
The tables below show the analysis dataset metadata and parameters used for this example.
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| Multiple | true |
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| Level | Dataset |
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| Purpose | Analysis |
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Dataset Name | Dataset Description | Class of Dataset | Structure | Keys | Documentation | Location |
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ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per subject | USUBJID | ADaMIG | adsl.xpt | | ADCVNTP | Cardiac Ejection Fraction and NTproBNP Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter | USUBJID, AVISITN, PARAMN | | adcvntp.xpt | | ADCVCMR | Cardiovascular CMR Ejection Fraction Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter | USUBJID, AVISITN, PARAMN | | adcvcmr.xpt |
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ADSL
The ADSL contains subject characteristics and covariates that are important for analyses. Stratification variables can be created in the ADSL to subset the data. More than one SDTM dataset may be used as input to the ADSL. This is a simplified example ADSL dataset; the ADaMIG should be referenced for additional variables.
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| Dataset2 |
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| | Row | STUDYID | USUBJID | BRTHDT | AAGE | AGE | AGEU | SEX | RACE | TRTSDT | RFICDT | DTHDT | DTHFL | TRT01P | ITTFL | ACEINHFL | HEIGHTSC | WEIGHTSC | BSASC |
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| 1 | DMD-EFLGE | DMD-EF-01-101 | 07FEB2010 | 12.3 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | 16JUN2022 | 16JUN2022 |
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| Drug A | Y | Y | 119 | 20 | 0.82 | | 2 | DMD-EFLGE | DMD-EF-01-101 | 01MAY2008 | 14.1 | 14 | YEARS | M | ASIAN | 13JUN2022 | 13JUN2022 |
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| Drug A | Y | Y | 115 | 30 | 0,95 | | 3 | DMD-EFLGE | DMD-EF-01-101 | 10JUL2003 | 19.0 | 19 | YEARS | M | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 15JUL22022 | 15JUL2022 |
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| Drug B | Y | N | 140 | 45 | 1,30 | | 4 | DMD-EFLGE | DMD-EF-01-101 | 15JAN1999 | 23.7 | 23 | YEARS | M | WHITE | 06SEP2022 | 06SEP2022 | 23NOV2023 | Y | Drug B | Y | Y | 132 | 42 | 1,21 |
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ADCVNTP
The ADCVNTP includes tests pertinent to analyses. The records from CV where CVTESTCD = "LVEF_C" and "RVEF_C" and the records from LB where LBTESTCD = "BNPPRONT" were selected. Many lab draws may occur throughout the year, but only those linked to a specific visit were included. By subsetting the LB dataset by LBLNKID not missing, laboratory data that aligns with CV data can be filtered out and sorted using USUBJID and VISIT. If LBLNKID is not available, a windowing strategy could be used to select the laboratory draw closest to that visit for merging with CV, computed in AVISIT.
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| Rowcaps |
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| Rows 1-2: | Show the baseline ejection fraction measurements at VISIT 1. | | Row 3: | Shows the baseline N-Terminal ProB-type Natriuretic Peptide test results at VISIT 1. | | Rows 4-5: | Show the baseline ejection fraction measurements at VISIT 6. | | Row 6: | Shows the baseline N-Terminal ProB-type Natriuretic Peptide test results at VISIT 6. |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | AAGE | AGEU | SEX | RACE | TRT01P | TRT01A | ITTFL | HEIGHT | WEIGHT | BSA | ACEINHFL | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | CHGCAT1 | SRCDOM | SRCVAR | SRCSEQ |
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| 1 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 119 | 20 | 0.82 | Y | Left Ventricular Ejection Fraction, Calculated (%) | LVEF_C | 1 | 67 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 67 |
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| CV | CVTESTCD | 3 | | 2 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 119 | 20 | 0.82 | Y | Right Ventricular Ejection Fraction, Calculated (%) | RVEF_C | 2 | 74 | Visit 1 (Baseline)) | 1 | VISIT 1 | 16MAY2022 | Y | 74 |
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| CV | CVTESTCD | 7 | | 3 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 119 | 20 | 0.82 | Y | N-Terminal ProB-type Natriuretic Peptide (IU/L) | BNPPRONT | 3 | 40 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 40 |
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| LB | LBTESTCD | 1 | | 4 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y | Left Ventricular Ejection Fraction, Calculated (%) | LVEF_C | 1 | 60 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 67 | -7 | -10.447761 | Decline >=5.0% | CV | CVTESTCD | 11 | | 5 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y | Right Ventricular Ejection Fraction, Calculated (%) | RVEF_C | 2 | 61 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 74 | -13 | -17.567568 | Decline >=5.0% | CV | CVTESTCD | 15 | | 6 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y | N-Terminal ProB-type Natriuretic Peptide (IU/L) | BNPPRONT | 3 | 900 | Visit 6 (1 Year) | 6 | VISIT 1 | 06APR2023 |
| 40 | 860 | 2,150 | Increase GT 100 pg/mL | LB | LBTESTCD | 2 |
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ADCVCMR
The ADCVMR is an efficacy analysis dataset with only a few records for more complex modeling of changes in ejection fraction, plus the ProB-type test results. It is an ADaM Basic Data Structure (BDS) dataset, with additional variables added from ADCVNTP.
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