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

Table 5 Incidence of central nervous system bleeding events in placebo- and tifacogin-treated patients with and without concomitant heparin use

MedDRA system organ class	Number (percentage) of subjects^a
	Heparin cohort		Non-heparin cohort
	Tifacogin	Placebo	0.025 TFPI	Placebo
	(n = 172)	(n = 167)	(n = 79)	(n = 78)
Any serious adverse event	5 (3%)	0	1 (1%)	0
Nervous system disorders	3 (2%)	0	0	0
Vascular disorders	2 (1%)	0	1 (1%)	0

^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.

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