Table 1.

Patients with thromboembolic events: selected demographics.

	Integrated Analysis
Patients With TEEs	4F-PCC (n = 14)	Plasma (n = 14)
Sex, No. (%)
Female	9 (64.3)	8 (57.1)
Age, y
Mean (SD) [range]	75 (13) [51–90]	72 (11) [50–92]
≥70, No. (%)	9 (64.3)	9 (64.3)
Type of bleeding, No. (%)*
GI/other nonvisible	4 (50.0)	5 (71.4)
Visible	1 (12.5)	0
ICH	3 (37.5)	0
Musculoskeletal	0	2 (28.6)
Type of surgery/procedure, No. (%)†
Cranial neurosurgical	0	1 (14.3)
Cardiothoracic surgical	0	1 (14.3)
Major orthopedic surgical	2 (33.3)	3 (42.9)
Other surgical	2 (33.3)	0
Invasive procedure	2 (33.3)	2 (28.6)
Reason for oral VKA therapy, No. (%)
Arrhythmia	9 (64.3)	10 (71.4)
Artificial heart valve or joint	0	1 (7.1)
Remote TEE	5 (35.7)	3 (21.4)
Use of anticoagulant at TEE	3 (21.4)	4 (28.6)

TEE, Thromboembolic event; GI, gastrointestinal; ICH, intracranial hemorrhage; VKA, vitamin K antagonist.

^*For patients enrolled in the bleeding study (NCT00708435) only.

^†For patients enrolled in the surgery study (NCT00803101) only.