Table 3:

Summary of adverse events (ITT-S population)

	4F-PCC (n=88)	Plasma (n=88)
Any adverse event	49 (56%)	53 (60%)
Related adverse event*	8 (9%)	15 (17%)
Adverse event leading to treatment discontinuation	0	0
Serious adverse event	22 (25%)	23 (26%)
Related serious adverse event*	3 (3%)	3 (3%)
Adverse events of interest
Deaths to day 45†	3 (3%)	8 (9%)
Thromboembolic adverse event‡	6 (7%)	7 (8%)
Fluid overload or similar cardiac event	3 (3%)	11 (13%)
Bleeding after primary outcome assessment	3 (3%)	4 (5%)

Adverse events with missing treatment associations were classified as related to treatment.

^*Defined as events that were related to study treatment according to the investigator.

^†One additional death in the 4F-PCC group occurred after study day 45 (day 48; worsening of cardiopulmonary disease).

^‡Thromboembolic adverse events included: six patients (seven events^§) in the 4F-PCC group (deep-vein thrombosis [two events], thrombosis, ischaemic stroke [two events], vena cava filter insertion, and catheter-related complication) and seven patients (seven events) in the plasma group (acute myocardial infarction [two events], deep-vein thrombosis, ischaemic stroke [two events], pulmonary embolism, and transient ischaemic attack).

^§One deep-vein thrombosis and one stroke occurred in the same patient. 4F-PCC=four-factor prothrombin complex concentrate. ITT-S=intention-to-treat safety.