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Table 3 Adverse events by treatment group

From: 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

  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 (1a) 1 (0) 0 (0) 1 (1b) 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)
  1. a Worsening anemia and empyema reported as possible related to placebo treatment
  2. b Hypoxic respiratory failure (study day 23) secondary to hospital-acquired pneumonia reported as possible related to study drug treatment