Table 3. Thromboembolic Events by Treatment Group.
| Thromboembolic event | No. (%) | Absolute difference (95% CI), %a | Relative risk (95% CI) | P valueb | |
|---|---|---|---|---|---|
| 4F-PCC (n = 164) | Placebo (n = 160) | ||||
| Patients with at least 1 thromboembolic event, No. (%) [No.] | 56 (35) [161] | 37 (24) [157] | 11 (1 to 21) | 1.48 (1.04 to 2.10) | .03 |
| Superficial venous thrombosis | 5 (3.1) | 1 (0.6) | 2 (−1 to 5) | ||
| Deep venous thrombosis | 27 (16.8) | 23 (14.6) | 2 (−6 to 10) | ||
| Pulmonary embolism | 20 (12.4) | 17 (10.8) | 2 (−5 to 9) | ||
| Strokec | 2 (1.2) | 0 | 1 (−1 to 3) | ||
| Otherd | 9 (5.6) | 5 (3.2) | 2 (−2 to 7) | ||
Abbreviation: 4F-PCC, 4-factor prothrombin complex concentrate.
a
Absolute differences were not adjusted.
b
χ2 test was used for the comparison.
c
Stroke was diagnosed using cerebral contrast-enhanced computed tomography.
d
Other includes extremity ischemia (n = 11), thrombosis of venous surgical anastomosis (n = 2), and mesenteric infarction (n = 1). There were no incidents of myocardial infarction in either group.