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Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent versions of the SDTM and ADaM controlled terminologies should be accessed through the CDISC website (https://www.cdisc.org/standards/terminology).

1.3   Known Issues

(Only include this section if there are any known issues; otherwise omit this. Describe any known issues.  If there is more than one known issue, use a bulleted list to describe the issues.)The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity of disease measurement and mortality estimation tool for adult patients typically admitted to intensive care units. The instrument consists of individual items that are summed up to create a total score. This instrument is generally collected once at Screening/Baseline and used as a predictor of mortality rather than an outcome measure. Individual items on this instrument are summed to create a total score but this total score is generally collected as part of the instrument with no instructions provided for handling missing data. In the majority of cases, where APACHE II is only assessed once and the collected total score used as a baseline covariate, the SDTM RS domain may be sufficient to support the analysis need.

2     Rules and References

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