Table 4.

Serious and non-serious treatment-emergent adverse events (TEAEs).

	Placebo (n = 153)	BCG (n = 148)	p-value
Total serious TEAEs, n (%)	3 (2.0)	1 (0.7)	0.623
Deaths	3 (2.0)	0 (0)	0.248
Acute pyelonephritis	1 (0.7)	0 (0)	1.00
Upper GI tract bleeding	0 (0)	1 (0.7)	0.498
Total non-serious TEAEs	10 (6.5)	9 (6.1)	1.00
Upper respiratory tract infection	7 (4.6)	0 (0)	0.015
Vaginal candidiasis	1 (0.7)	0 (0)	1.00
Hot flashes	1 (0.7)	0 (0)	1.00
Pain/erythema at the injection site	0 (0)	5 (3.4)	0.028
Pustule/edema at the injection site	1 (0.7)	2 (1.4)	0.618
Varicella-zoster infection	0 (0)	1 (0.7)	0.492
Hyperparathyroidism	0 (0)	1 (0.7)	0.492

The events that are related to COVID-19-related symptoms are not reported in this Table.