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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.