Table 5.
Safety Outcomes Among all Recipients of Prothrombin Complex Concentrate (PCC): Numbers of Affected Patients (%).
| Event | Prophylactic Cohort (n = 21) | Treatment Cohort (n = 347) | Both Cohorts Combined (n = 368) |
|---|---|---|---|
| Any adverse drug reactiona | 1 (4.8)b | 6 (1.7)c | 7 (1.9) |
| Drug ineffective | 0 (0.0) | 6 (1.7) | 6 (1.6) |
| Hemorrhage | 0 (0.0) | 3 (.9) | 3 (.8) |
| Thromboembolic event | 1 (4.8) | 6 (1.7) | 7 (1.9)d |
| Cerebral ischemic event | 0 (0.0) | 5 (1.4) | 5 (1.4) |
| Myocardial infarction | 1 (4.8) | 1 (.3) | 2 (.5) |
| Death | 3 (14.3) | 9 (2.6) | 12 (3.3) |
aExcluding thromboembolic events and deaths.
bOne patient had relapsed acute promyelocytic leukemia and acute myocardial infarction
cDetails of the adverse drug reactions in these 6 patients are as follows: “drug ineffective” (3 patients); “drug ineffective” and hemorrhage (2 patients); and atrial fibrillation, atrial flutter, cerebral infarction, cerebrovascular accident, delayed recovery from anesthesia, disturbance in attention, “drug ineffective,” hemorrhage, hemiparesis, mechanical ventilation, nervous system disorder, pericardial hemorrhage, retinal artery embolism, tracheostomy, unresponsive to stimuli, ventricular arrhythmia, vision blurred, and visual acuity reduced (1 patient)
dAdditional treatment was administered to these patients as follows: platelet concentrate (n = 7), vitamin K (n = 6), desmopressin (n = 6), cryoprecipitate (n = 6), red blood cells (n = 5) and fibrinogen (n = 1; see Supplementary Table 1).