Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

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. 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.

...