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Table 4 Safety of ART-123 in France and ROW

From: Efficacy and safety of human soluble thrombomodulin (ART-123) for treatment of patients in France with sepsis-associated coagulopathy: post hoc analysis of SCARLET

Event, n (%)

France

ROW

ART-123 (n = 76a)

Placebo (n = 73)

Total (n = 149)

Total (n = 651)

TEAE

75 (98.7)

70 (95.9)

145 (97.3)

609 (93.5)

TESAE

38 (50.0)

36 (49.3)

74 (49.7)

334 (51.3)

On-treatment SMBE

5 (6.6)

4 (5.5)

9 (6.0)

30 (4.6)

  1. ROW rest of world (excluding France), SMBE serious major bleeding event, TEAE treatment-emergent adverse event, TESAE treatment-emergent serious adverse event
  2. aOne patient randomized to the placebo group received a dose of ART-123