Table 4. Adverse Events and Other Measured Outcomes at 28-Day Follow-up.

Outcome	No. (%) of patients [No. of events]
	PCC group (n = 54)	FP group (n = 47)
Any adverse eventa	42 (77.8) [108]	41 (87.2) [102]
Any serious adverse eventa	19 (35.2) [29]	14 (28.6) [22]b
No.		49
Thromboembolic adverse eventsa	4 (7.4) [4]	4 (8.2) [5]b
No.		49
Stroke or TIA	2	3
Atrial thrombosis	0	1
Vascular thrombosis	2	1
Acute kidney injury, No. (%)c	4 (7.4)	3 (6.1)
Duration of mechanical ventilation, median (IQR), d	0.5 (0.4-0.9)	0.6 (0.4-0.9)
Duration of intensive care unit stay, median (IQR), d	2.0 (1.0-4.8)	3.0 (1.1-4.8)
Duration of hospitalization, median (IQR), dd	9.3 (8.0-13.7)	12.3 (9.2-14.5)

Abbreviations: FP, frozen plasma; IQR, interquartile range; PCC, prothrombin complex concentrate; TIA, transient ischemic attack.

^aPatients who experienced more than 1 event are counted only once in the totals.

^bIncludes data on 2 patients for whom informed consent could not be obtained but research ethics board approval was obtained to collect serious adverse events.

^cAcute kidney injury was defined as greater than 2-fold increase in creatinine or kidney failure requiring hemodialysis within 28 days of surgery.

^dCensored at 28 days.