Table 4. Review of safety outcomes.

	EPIC (N = 395) % (n)	Control (N = 446) % (n)
Any patient with an adverse event	24.8 (98)	27.1 (121)
Total of adverse events	145	168
Type
Mild AE	1.8 (7)	0.2 (1)
Moderate AE	2.3 (9)	1.6 (7)
Severe AE	12.9 (51)	12.1 (54)
Serious adverse events	19.7 (78)	23.8 (106)
Relatedness
Not related AE	35.2 (139)	NA
Possible related AE	0.8 (3)	NA
Probable related AE	0.8 (3)	NA
Association
Associated to concomitant disease	22 (87)	18.4 (82)
Associated to concomitant medication	0.5 (2)	0
Associated to COVID-19	33.4 (132)	35.6 (159)

NA: Not applicable