Table 4.

Safety analysis for patients included in the study. Values are number or number (proportion).

	PCC group n = 29	FFP group n = 26
Total number of adverse events	75	62
Patients with adverse events	22 (76%)	19 (73%)
Total number of serious adverse events	5	13
Patients with serious adverse events	4 (14%)	9 (35%)
Types of serious adverse events*
Resulting in death	1	1
Heart failure	1
Heart valve incompetence		1
Life‐threatening	2	2
Heart failure †		1
Mesenteric artery thrombosis	1
Multiple organ failure	1
Pulseless electrical activity †		1
Re‐hospitalisation or prolonged hospitalisation	1	9
Abdominal pain ‡		1
Chest pain ‡		1
Malaise ‡		1
Heart failure		1
Hypotension		1
Haemothorax §		1
Pleuritic pain		1
Raised INR	1
Stroke §		2
Persistent or significant disability	1	1
Spinal cord ischaemia	1
Stroke		1

PCC, prothrombin complex concentrate; FFP, fresh frozen plasma; INR, international normalised ratio.

^*Thromboembolic events are classified as serious adverse effects, there were no venous thromboses in either arm.

^†Two life‐threatening serious adverse events were for one patient in the FFP arm.

^‡Three hospital re‐admissions were from the same patient in the FFP arm.

^§Haemothorax resulted in re‐admission, and a stroke during that admission, led to prolonged hospitalisation for one patient.