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. Author manuscript; available in PMC: 2019 Aug 20.
Published in final edited form as: Circulation. 2013 Aug 9;128(11):1234–1243. doi: 10.1161/CIRCULATIONAHA.113.002283

Table 7.

Rapid INR Reduction (Intention-to-Treat Efficacy Population)

No. (%) of Patients [95% CI]
4F-PCC
(n=98)		 Plasma
(n=104)		 Difference 4F-PCC Minus
Plasma, % (95% CI)
Rapid INR reduction* 61 (62.2) 10 (9.6) 52.6†
[52.6 to 71.8] [3.9 to 15.3] (39.4 to 65.9)

4F-PCC indicates 4-factor prothrombin complex concentrate; CI, confidence interval; and INR, international normalized ratio.

*

INR <1.3 at 0.5 h after end of infusion.

†

4F-PCC noninferior to plasma: lower limit of 95% CI more than −10% Farrington-Manning P value for noninferiority P<0.0001 rejecting null hypothesis of inferiority of 4F-PCC; 4F-PCC superior to plasma: lower limit of 95% CI >0.