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- From CV domain
- Percent change in ejection fraction
- Decline in ejection fraction over a time period (yearly) grouped by a decline greater than x.x%.
- From the LB domain
- Percent change in NTproBNP over a period of time (yearly).
The example study
For this example we show the following endpoints from the SDTM dataset:
- CV - Percent change in ejection fraction, decline in EF over a time period (yearly) grouped by declinde greater than x%.
- LB - Percent change in NTproBNP over a period of time (yearly)
SDTM examples are in the section Basic CMR tests -Systolic Function (make link) . The example datasets show visits 1 and 6 for one subject. As mentioned in the SDTM text, for the purposes of this example, the participant was enrolled in the study on 20-May-2021 and the study visits were every two months. Visit 1 represents the visit at day 1 of the study, and visit 6 represents the visit at month 12 of the study.
Questions. Questions:
Is screening considered visit 1, or is it to include the subject into the study?
Are these Real World Evidence (RWE) studies only or clinical trials?
Should both endpoints be shown in one efficacy dataset or two?
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