Figure 3. Primary and co-primary endpoints.
Figure shows effective haemostasis (haemostatic efficacy rating of excellent or good) and rapid INR reduction (INR ≤1·3 at 0·5 h after end of infusion) by non-inferiority analysis in the ITT-E population. Treatment difference refers to between-group difference of 4F-PCC minus plasma. Tinted area shows zone of non-inferiority, bounded by non-inferiority margin (dotted line) set at −10%. Superiority margin was set at 0% (solid line), meaning that 4F-PCC is superior to plasma if the lower limit of the 95% CI is to the right of the solid line. 4F-PCC=four-factor prothrombin complex concentrate. INR=international normalised ratio. ITT-E=intention-to-treat efficacy.