Table 4.

Adverse events

	Colchicine (n=366)	Placebo (n=348)	p-value
Chest pain, %	33 (9.0)	25 (7.2)	0.45
Gastrointestinal symptoms, %	34 (9.3)	11 (3.2)	0.001
Hypersensitivity reaction, %	4 (1.1)	4 (1.1)	0.99
Access site discomfort, %	4 (1.1)	4 (1.1)	0.99
Hemodynamic instability, %	0	5 (1.4)	0.03
Fever, %	0	2 (0.6)	0.24
Elevated creatinine, %	1 (0.3)	2 (0.6)	0.62
Ischemic stroke, %	1 (0.3)	0	0.99
Fluid overload, %	1 (0.3)	1 (0.3)	0.99
Urinary retention, %	2 (0.5)	0	0.50
Bleeding, %	1 (0.3)	2 (0.6)	0.62
Palpitations, %	0	1 (0.3)	0.49
Headache, %	1 (0.3)	0	0.99
Serious adverse events total, %	5 (1.4)	12 (3.4)	0.11

Categorical data are presented as frequency (proportion) and compared using chi-square test, or fisher’s exact test if the cell number is less than 5.