In PROWESS, placebo patients received either 0.1% albumin or saline.
In PROWESS, a statistically significant treatment-by-enrollment interaction was also observed (P = 0.007) (Table 2).
In PROWESS, this enrollment sequence effect reduced the observed treatment effect associated with DrotAA.
In PROWESS, protein C levels were measured daily on study days 1 to 7, 14 and 28. Figure 1 shows sequential protein C measurements in PROWESS placebo patients grouped by duration of survival [ 34].
In PROWESS, randomization was stratified only by site, resulting in a uniform block size of four at each site.
In PROWESS, no difference in markers of coagulopathy between Ab-positive and Ab-negative patients was observed.
In PROWESS, mortality was lower with DrotAA treatment for the second and subsequent patients enrolled at a site.
In PROWESS, approximately 90% of patients started study drug within 24 hours [ 1], whereas in ADDRESS this was only 50%.
In PROWESS more than 70 subgroup analyses have demonstrated a consistent reduction in 28-day mortality when treated with DrotAA.
In PROWESS the incidence of serious bleeding events during the 28-day study period was 3.5% in DrotAA-treated and 2.0% in placebo-treated patients.
In PROWESS [ 3], approximately 40% of subjects had severe protein C deficiency [ 11] while in our study only approximately 20% had a similar deficiency.
