Table 4.

List of Severe Adverse Events and Non-severe Adverse Events Reported during the Study Period

Serious Adverse Events (SAEs)	Placebo (N = 78)	BCG (N = 72)	p value
Presence of at least one SAE,a no. (%)	30 (38.5)	17 (23.6)	0.055
Death — no. (%)	8 (10.3)	5 (6.9)	0.568
SAEs with hospitalization,a no. (%)	20 (25.6)	10 (13.9)	0.101
Reason for hospitalization, no. (%)
Arrythmia	1 (1.3)	0 (0)	1.000
Stroke	2 (2.6)	1 (1.4)	1.000
Acute kidney injury	0 (0)	1 (1.4)	0.480
Deep vein thrombosis	1 (1.3)	0 (0)	1.000
Epilepsy	1 (1.3)	0 (0)	1.000
Electrolyte disturbance	1 (1.3)	0 (0)	1.000
Pulmonary edema	1 (1.3)	0 (0)	1.000
Anemia	1 (1.3)	0 (0)	1.000
ST-segment elevation at ECG	1 (1.3)	0 (0)	1.000
Elective surgery	2 (2.6)	2 (2.8)	1.000
SAEs without hospitalization, no. (%)
Stroke, no. (%)	1 (1.3)	0 (0)	1.000
Syncope	0 (0)	1 (1.4)	0.480
Anemia	1 (1.3)	0 (0)	1.000
Non-serious adverse events (AEs)
At least one non-serious AE,a no. (%)	20 (25.6)	26 (36.1)	0.215
Type of non-serious AE, no. (%)
Varicella-zoster eruption	1 (1.3%)	0 (0)	1.000
Helicobacter pylori infection	3 (3.8)	0 (0)	0.246
Dacryocystitis	0 (0)	1 (1.4)	0.480
Hip fracture	2 (2.6)	0 (0)	0.490
Non-infection associated cough	4 (5.1)	11 (15.3)	0.055
Asymptomatic bacteriuria	2 (2.6)	7 (9.7)	0.088
Breast cancer	1 (1.3)	1 (1.4)	1.000
Renal cancer	0 (0)	1 (1.4)	0.480
Squamous skin carcinoma	0 (0)	1 (1.4)	0.480
Rash at the injection site	0 (0)	2 (2.8)	0.229
Otitis	0 (0)	1 (1.4)	0.480
Dental infection	2 (2.6)	1 (1.4)	1.000

SAEs and deaths due to infections counting against the primary endpoint are not encountered here since per protocol they should not be reported as adverse events.

^aSome patients had more than one SAE and/or more than one AE.