Table 5.
Hemostatic Efficacy (Intention-to-Treat Efficacy Population)
| Primary Rating | No. (%) of Patients [95% CI] |
Difference 4F-PCC Minus Plasma, % (95% CI) |
|
|---|---|---|---|
| 4F-PCC (n=98) |
Plasma (n=104) |
||
| Hemostatic efficacy rating by category* | |||
| Excellent | 44† (44.9) | 45† (43.3) | |
| Good | 27 (27.6) | 23 (22.1) | |
| Poor/none | 27 (27.6) | 36 (34.6) | |
| Noneffective | 25 (25.5) | 33 (31.7) | |
| Missing primary rating | 2 (2.0) | 3 (2.9) | |
| rating | |||
| Effective hemostasis | 71 (72.4) | 68 (65.4) | 7.1‡ (−5.8 to 19.9) |
| [63.6 to 81.3] | [56.2 to 74.5] | ||
Effective hemostasis indicates hemostatic efficacy rated as excellent or good. 4F-PCC indicates 4-factor prothrombin complex concentrate; and CI, confidence interval.
*
Hemostatic efficacy assessed by a blinded independent board
†
P=0.50 by Cochran–Mantel–Haenszel test.
‡
4F-PCC noninferior to plasma: lower limit of 95% CI more than −10% Farrington–Manning P value for noninferiority P=0.0045 rejecting null hypothesis of inferiority of 4F-PCC.