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Table 3 Incidence rates of total adverse events and adverse events associated with the study medication, list of serious adverse events, and mortality numbers and rates

From: Double-blind controlled trial of lecithinized superoxide dismutase in patients with idiopathic interstitial pneumonia – short term evaluation of safety and tolerability

  Placebo (n = 18) 40 mg PC-SOD (n = 18) P-value* 80 mg PC-SOD (n = 19) P-value*
Number of patients with at least 1 adverse event (%) 15 (83.3) 16 (88.9) 1.000 19 (100.0) 0.105
Number of patients with at least 1 adverse event directly associated with PC-SOD (%) 8 (44.4) 14 (73.7) 0.184
Serious adverse event, n (%)      
Myocardial ischemia 0 (0.0) 1 (5.6) 1.000 0 (0.0)
Pneumonia 1 (5.6) 0 (0.0) 2 (10.5) 1.000
Pneumothorax 0 (0.0) 0 (0.0) 2 (10.5) 1.000
Pulmonary embolism 0 (0.0) 1 (5.6) 1.000 0 (0.0)
Interstitial lung disease 3 (16.7) 3 (16.7) 1.000 3 (15.8) 1.000
Pneumomediastinum 0 (0.0) 0 (0.0) 1 (5.3) 1.000
Febrile disorders 1 (5.6) 1 (5.6) 1.000 0 (0.0)
Acute respiratory failure 0 (0.0) 0 (0.0) 1 (5.3) 1.000
Mortality, n (%) 3 (16.7) 2 (11.1)   2 (15.8)  
  1. *Fisher’s direct probability test vs. placebo.
  2. Fisher’s direct probability test vs. 40 mg PC-SOD.
  3. Nine patients were required to stay in the hospital over the study period because of progression of interstitial lung disease.
  4. Definition of abbreviation: PC-SOD = lecithinized superoxide dismutase.
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