. 2021 Dec 14;326(22):2277–2286. doi: 10.1001/jama.2021.20956

Table 4. Safety Outcomes.

Safety outcome (as-treated population)	Overall outcome rate, patients with event/No. of patients (%)		Risk (95% CI)^a		Mantel-Haenszel test P value
Safety outcome (as-treated population)	Device	No device^b	Difference, %	Relative	Mantel-Haenszel test P value
Any serious adverse event	506/1762 (28.7)	516/1956 (26.4)	1.97 (−0.89 to 4.82)	1.07 (0.97 to 1.19)	.18
Atrial fibrillation
All events	88/1762 (5.0)	21/1956 (1.1)	3.77 (2.65 to 4.89)	4.54 (2.78 to 7.39)	<.001
Present beyond 45 d	43/1762 (2.4)	16/1956 (0.8)	1.38 (0.56 to 2.19)	2.60 (1.44 to 4.70)	.001
Major bleeding episode^c	25/1762 (1.4)	33/1956 (1.7)	−0.31 (−1.09 to 0.47)	0.80 (0.47 to 1.40)	.45
Venous thromboembolism	25/1762 (1.4)	10/1956 (0.5)	0.87 (0.22 to 1.51)	2.59 (1.26 to 5.36)	.007

^{^a}

Stratified by study using Cochran-Mantel-Haenszel tests.

^{^b}

Data from 105 patients who were assigned to device but did not receive device were analyzed in the medical therapy group. The median follow-up times from randomization for patients receiving device and not receiving device were 58.7 months (IQR, 23.8-64.0) and 50.0 months (23.8-63.6), respectively.

^{^c}

Major bleeding episode was derived from serious adverse event reporting in each of the individual trials.