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
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) |