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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