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

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)

*Fisher’s direct probability test vs. placebo.
^†Fisher’s direct probability test vs. 40 mg PC-SOD.
^¶Nine patients were required to stay in the hospital over the study period because of progression of interstitial lung disease.
Definition of abbreviation: PC-SOD = lecithinized superoxide dismutase.

ISSN: 1471-2466