Page History

...

In this example, the APACHE II was measured within 24 hours of ICU admission, on or before Day 1 (prior to implementation of treatment), Day 7, and Day 15 or on the day of discharge (whichever was earlier). In the example, as per the SAP, subjects who died on Day 15 or earlier were assigned the highest observed APACHE II score of any of the subjects at any time during the trial (worst case imputation for deaths). This imputation method is for example purposes only and not meant to be a recommendation nor considered a common practice. Missing data values for the parameters required for the derivation of the APACHE II score were replaced by the last available assessment. Item level imputation, in this example, is handled by the investigators and/or clinicians at the site and is considered source data, already captured in SDTM. The  --LNKID variable can be used to determine the source or input record used to assess that particular physiological item on APACHE II at that time point. RSLNKID was not included in the dataset because we already have RSSEQ for traceability back to SDTM, and within RS, RSLNKID provides traceability to the source records in other domains. SOC included a variety of supportive therapies that ranged from the administration of supplementary oxygen to full intensive care support, alongside the use of antiviral treatment, convalescent plasma, corticosteroids, antibiotics or other agents.

...