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The example dataset described here is intended to support a variety of analyses, ranging from simple univariate summary statistics on the actual total scores to other types of by-visit and repeated-measure analyses. For that reason, standard ADaM BDS variables such as AVAL (analysis value) have been included in the example. In addition, although not illustrated in the example, the APACHE II total score can be divided into categories reflecting disease severity or risk of death and the frequency of subjects reporting in each category may be generated or used for analysis.

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The ADAPCH Variable Metadata table contains an example of analysis variable metadata for a subset of possible variables available for the APACHE II. Example value-level metadata are found in the Parameter Value Level List - ADAPCH [AVAL] metadata table. The ADAPCH Variable Metadata table does not include all of the possible variables that may be present in the Subject-Level Analysis Dataset (ADSL) and copied to the BDS structure analysis dataset, with the exception of the required STUDYID and USUBJID. For a complete list of available ADSL variables, consult the ADaMIG. Some ADSL variables (e.g., REGION1) were included in this example for stratification, and are not required. Additional covariates or other variables may be added as needed for analysis. Common BDS variables such as BASE and CHG have been omitted as they are not typically mentioned in documentation on APACHE II. There is no specific ordering of variables recommended in this supplement. The SDTM variables were placed next to the corresponding derived ADaM variables for illustration purposes only. 

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