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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 readings chosen to analyze ejection fraction are the Left Ventricular Ejection Fraction, Cal. The example dataset also shows the Right Ventricular Ejection Fraction, Cal which can be used to confirm the result. The example dataset in Section 2.1 shows 2 visits for subject DMD-EF-01-101. The records for  The records in the CV dataset for which CVTESTCD = "LVEF_C" and "RVEF_C" were selected for analysis.  

The NT-proBNP test is stored in the LB domain. The example dataset in Section 2.1 shows the test in the example LB dataset (LBTESTCD  = "BNPPRONT"). The lab value was used to compute the percent change over time for the third endpoint and as a potential covariate for the ejection fraction models.

The example ADaM

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Subject-level Analysis (ADSL) dataset draws from the DM dataset for demographics and study dates. It draws from Vital Signs (VS) for height and weight at screening. The VS is also used for height and weight at each visit, which in turn is used to compute body surface area (BSA), an important measure used in calculations for basic systolic functions. A flag for angiotensin-converting enzyme (ACE) inhibitor medications was added to the example. The source for this data would be concomitant medications (CM) or dosing information (EX, EC), not shown.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

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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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For this example:

  • Analysis age (AAGE) was included to provide age with more precision.
  • A flag indicating the use of ACE inhibitors (ACEINHFL) is shown with example derivation from the CM dataset.
  • Body surface area at screening (BSASC) was derived from the VS dataset using height and weight at the screening visit. There are many possible calculations for BSA; for this example, the Du Bois method was used.[11] Note that the screening visit and visit 1 occurred at the same time in this example.

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