A phase I study evaluating the pharmacokinetics, safety and tolerability of an antibody-based tissue factor antagonist in subjects with acute lung injury or acute respiratory distress syndrome

Table 3 Adverse events by treatment group

	Placebo	0.06 mg/kg ALT-836	0.08 mg/kg ALT-836	0.10 mg/kg ALT-836	Total
	(n = 3)	(n = 5)	(n = 5)	(n = 5)	(n = 18)
Mortality by study day 28 (treatment related)	0 (0)	0 (0)	1 (0)	0 (0)	1 (0)
Patients with non-fatal SAEs (treatment related)	2 (1^a)	1 (0)	0 (0)	1 (1^b)	5 (2)
Total number of AEs (treatment related)	20 (2)	18 (3)	29 (5)	20 (6)	87 (16)
Patients with hematuria AEs (treatment related)	0 (0)	2 (2)	2 (2)	5 (4)	9 (8)
Patients with anemia AEs (treatment related)	2 (2)	1 (1)	2 (2)	3 (0)	8 (5)

^a Worsening anemia and empyema reported as possible related to placebo treatment
^b Hypoxic respiratory failure (study day 23) secondary to hospital-acquired pneumonia reported as possible related to study drug treatment

ISSN: 1471-2466