Table 5.

Comparison of Adverse Events in Placebo versus Corticosteroid Treatment Arms within the P. aeruginosa Subgroup

	Placebo (n = 51)*n (%)	Corticosteroid (n = 59)*n (%)	P†
Change in antibiotic/addition of other antibiotic‡	11 (22)	4 (7)	0.03
Corneal perforation	1 (2)	1 (2)	>0.99
Death	1 (2)	1 (2)	>0.99
IOP elevated >25 but ≤35 mm Hg with medications within 1 week of therapy§	3 (6)	1 (2)	0.34
Increase in infiltrate size (>50%) and >1 mm in maximum diameter	1 (2)	0 (0)	0.46
No resolution of epithelial defect at 21 days or later	6 (12)	13 (22)	0.21
Progressive corneal thinning ≥50% of enrollment thickness	1 (2)	0 (0)	0.46
Recurrence of epithelial defect	0 (0)	1 (2)	>0.99
Total subjects with any adverse events	12 (24)	15 (25)	>0.99

^*Adverse events were recorded from enrollment until the 3-month follow-up. These values (n) reflect the number of cases at enrollment.

^†Fisher's exact test.

^‡Other antibiotics included gentamicin, ceftazidime, amikacin, doxycycline, tobramycin, and ciprofloxacin.

^§IOP elevation >35 was considered a serious adverse event. There were no cases of IOP elevation >35 in SCUT.