. 2023 Feb 2;29(6):781–788. doi: 10.1016/j.cmi.2023.01.019

Table 3.

Safety endpoints

Endpoint	Intervention	Number of subjects	FU time^a	Number of events	Cumulative incidence	SDHR
First non-serious adverse event	Placebo	3054	1121.0	1213	0.399 (0.382–0.416)	[ref]
First non-serious adverse event	BCG	3058	641.5	2047	0.671 (0.654–0.687)	2.51 (2.35–2.69)
First serious adverse event	Placebo	3054	1453.1	216	0.071 (0.062–0.080)	[ref]
First serious adverse event	BCG	3058	1447.0	251	0.082 (0.073–0.092)	1.17 (0.97–1.40)
Death	Placebo	3054	1510.6	18	0.006 (0.004–0.009)	[ref]
Death	BCG	3058	1514.7	13	0.004 (0.002–0.007)	0.71 (0.35–1.43)
First cardiac arrhythmia event	Placebo	3054	1500.4	35	0.011 (0.008–0.016)	[ref]
First cardiac arrhythmia event	BCG	3058	1502.5	45	0.015 (0.011–0.020)	1.29 (0.83–2.01)
First coronary artery disorder event	Placebo	3054	1508.1	9	0.003 (0.001–0.005)	[ref]
First coronary artery disorder event	BCG	3058	1509.1	22	0.007 (0.005–0.011)	2.44 (1.12–5.32)

BCG, Bacillus Calmette-Guérin; FU, follow-up; SDHR: sub-distribution hazard ratio; [ref], reference category.

Follow-up time (person-years). This includes the time until the first event, occurrence of a competing event, loss to follow-up, or day 182, whichever occurred first.