Page History

...

The example dataset described here is intended to support a variety of analyses, ranging from simple univariate summary statistics on both the actual total scores and change in total score from baseline by visit to other types of by-visit and repeated-measure analyses. For that reason, standard ADaM BDS variables such as AVAL (analysis value) and CHG (change from baseline) have been included in the example. In addition, 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.

In the example presented here, it is assumed that the final APACHE II analysis dataset (ADAPCH) contains all of the original records, plus a record for the computed total acute physiology score and a record for the computed total APACHE II for each patient and assessment timepoint. The date of the assessment—and time of the assessment, if collected—should also be included in the dataset. For traceability, raw item-level responses from the SDTM RS.RSORRES variable, stored separately from the analysis variable AVAL, are included. Derivation type (DTYPE) should be used to clearly indicate records where missing values have been imputed using sponsor-defined imputation methods. If useful for analysis, a summary analysis dataset which includes only the computed total score records may also be created.

...