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The APACHE II Analysis Dataset tables below show the terminology and variables for implementing the example analysis dataset for this instrument in the BDS. This specific example is taken from a Phase II, randomized, controlled, open label multi-center study to assess the efficacy and safety of Drug A for the treatment of SARS-CoV-2 infected subjects with COVID-19 pneumonia and impaired respiratory function. The primary outcome measure is APACHE II Severity of Disease Score on Day 15 or on the Day of Discharge (whichever is earlier). This measure compares "Drug A + Standard of Care SOC" with "SOC" (SOC ) versus the = Standard of Care (SOC). 

In this example, the APACHE II score was measured on 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, participants subjects who died on Day 15 or earlier were assigned the highest observed APACHE II score of any of the participants 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 of 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. 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.

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