Page History

...

The APACHE II Summary Analysis Dataset table shows the terminology and variables for implementing the example analysis dataset for this instrument in the BDS. This specific example is taken from a multicenterPhase 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 patients 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) versus the Standard of Care (SOC). 

APACHE II score was measured on Day 15 or on the day of discharge (whichever was earlier). Participants 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). Missing data values of the parameters required for the derivation of the APACHE II score were replaced by the last available assessment. 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.

double-blind, active-controlled parallel design study conducted in elderly patients with major depressive disorder. The purpose of the analysis is to compare the effect of Drug A to Drug B on depression in elderly patients using the APACHE II to construct an endpoint. All analyses are conducted on an intent-to-treat basis, and the planned duration of treatment is 5 months. The baseline measurement is defined as the last non-missing value collected at or prior to the start of treatment; change from the last non-missing post-baseline value to baseline is used to construct an endpoint. The SAP specifies that planned collected visits, including baseline measurements, are to be used in analyses and displays of results, whereas unscheduled visits appear only in listings. The total score records for 1 subject were collected at 3 visits, plus a derived last observed value (LOV) endpoint record for the APACHE II. Visit 1 is remapped to AVISIT = "BASELINE". There are 2 visits at AVISIT = "VISIT 2". However, because 1 visit was unscheduled, it is not used in the analysis and the ANL01FL value is null. Visits 5 and 6 are missing because the subject discontinued early due to an adverse event unrelated to treatment.

...