Page History

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• From CV domain
  • Percent change in ejection fraction over time
  • Decline in ejection fraction over a time period (yearly) grouped by a decline greater than 10.0%.
• From the LB domain
  • Percent change in NTproBNP over a period of time (yearly).

Source Data

The SDTM examples used as the source data are from Section 2.1, Basic CMR Tests - Systolic Function. The CV dataset contains 16 rows, 1-8 for visit 1 and 9-16 for visit 6. Of these rows, the ones where CVTESTCD = "LVEF_C" and "RVEF_C" were used for analysis. In the LB dataset, the records where LBTESTCD = "BNPPRONT" were used to compute the percentage change over time, then added as a potential covariate in each row for the last analysis. The SDTM datasets were merged with a Subject Level Analysis Dataset (ADSL) dataset to record the demographics, treatments and other appropriate variables for analysis.

ADaM Datasets

The example analysis dataset includes treatment and demographic information drawn from the ADSL, defined in the metadata table below. In this example, only some of the required variables, plus important stratification variables from ADSL, are shown for illustrative purposes. For example, body surface area at baseline (BSABL) was computed for baseline records in ADSL. However, since the subjects are children, the body surface area changes over time. Therefore, it would probably be necessary to have a separate dataset to represent this over time.

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ADSL Analysis Dataset

ADCVNTP Analysis Dataset

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Example Analysis Results Metadata (ARM) Tables

This is an example ARM table for the selected endpoint. Other endpoints can be represented in the same way describing the variables and procedures used. For more details on ARM, see the ADaMIG and the ARM implementation in Define-XML (available at https://www.cdisc.org/standards/foundational/define-xml/).

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