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Table 2 Primary endpoint: presence or absence of DIC recovery on day 6 (or at withdrawal)

From: An open-label, randomized, phase 3 study of the efficacy and safety of antithrombin gamma in patients with sepsis-induced disseminated intravascular coagulation syndrome

AT activity (%) DIC recovery
pAT AT gamma
% (n/N) % (n/N)
< 50 46.5 (20/43) 46.3 (19/41)
50–70 56.5 (39/69) 61.8 (42/68)
Total [95% CI] 52.7 (59/112) [43.0–62.2] 56.4 (62/110) [46.6–65.8]
Adjusteda [95% CI] 52.7 [43.6–61.9] 55.9 [46.7–65.1]
  1. AT antithrombin, CI confidence interval, DIC disseminated intravascular coagulation, pAT plasma-derived antithrombin
  2. aThe protocol was amended to include all patients with AT activity ≤ 70% so that the patient population would more accurately reflect the intended clinical use. The (adjusted) DIC recovery rate and its 95% CI were calculated for each treatment group after stratification (using the Woolson–Bean method) by the AT activity (< 50%, 50–70%) at study enrollment