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Table 4 Incidence of serious bleeding adverse events in patients with and without concomitant heparin use

From: A clinical evaluation committee assessment of recombinant human tissue factor pathway inhibitor (tifacogin) in patients with severe community-acquired pneumonia

MedDRA system organ class Number (percentage) of subjectsa
  Heparin cohort Non-heparin cohort
  Tifacogin Placebo 0.025 TFPI Placebo
  (n = 172) (n = 167) (n = 79) (n = 78)
Any serious adverse event 11 (6%) 4 (2%) 3 (4%) 2 (3%)
Gastrointestinal disorders 1 (1%) 2 (1%) 2 (3%) 2 (3%)
General disorders and administration site condition 1 (1%) 1 (1%) 0 0
Injury and poisoning 0 1 (1%) 0 0
Nervous system disorders 3 (2%) 0 0 0
Respiratory, thoracic, and mediastinal disorders 1 (1%) 0 0 0
Surgical and medical procedures 2 (1%) 0 0 0
Vascular disorders 3 (2%) 0 1 (1%) 0
  1. aNumber and percentage of subjects with one or more events that map to each MedDRA system organ class. Hence, MedDRA system organ class counts may not equate with overall counts. MedDRA, Medical Dictionary for Regulatory Activities; TFPI, tissue factor pathway inhibitor.