Table 3.
Distribution of serious adverse events (SAEs) and causes of death
| SAE description^ | CCT (n = 195) |
VHA (n = 201) |
||
|---|---|---|---|---|
| Events | Patients | Events | Patients | |
| Infection | 34 (34%) | 30 (32%) | 35 (31%) | 29 (29%) |
| Thromboembolic^^ | 24 (24%) | 22 (24%) | 16 (14%) | 15 (15%) |
| Ischemic | 0 (0%) | 0 (0%) | 6 (5%) | 6 (6%) |
| Organ failure | 5 (5%) | 5 (5%) | 9 (8%) | 9 (9%) |
| Acute kidney injury | 6 (6%) | 6 (6%) | 6 (5%) | 6 (6%) |
| Acute lung injury | 6 (6%) | 5 (5%) | 12 (11%) | 8 (8%) |
| New onset major bleeding | 9 (9%) | 9 (10%) | 6 (5%) | 6 (6%) |
| Cardiac | 6 (6%) | 6 (6%) | 10 (9%) | 10 (10%) |
| Neurological | 0 (0%) | 0 (0%) | 4 (4%) | 4 (4%) |
| Other | 11 (11%) | 10 (11%) | 8 (7%) | 8 (8%) |
| Total | 101 (100%) | 93 (100%) | 112 (100%) | 101 (100%) |
| Cause of Death | Patients | Patients |
|---|---|---|
| Uncontrolled Bleeding | 17 (30%) | 13 (25%) |
| Head Injury | 19 (34%) | 16 (30%) |
| Multiple Organ Dysfunction | 6 (11%) | 10 (19%) |
| Thromboembolism | 0 (0%) | 2 (4%) |
| Multiple Injuries | 4 (7%) | 1 (2%) |
| Other | 10 (18%) | 9 (17%) |
| Unknown | 0 (0%) | 2 (4%) |
| Total | 56 (100%) | 53 (100%) |
Serious Adverse Events (SAEs) were defined as any adverse event, adverse transfusion reaction or unexpected adverse transfusion reaction that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, resulted in a congenital anomaly/birth defect or other medically significant event
^In the event field, SAEs experienced multiple times by the same patient are included in the count. In the patients field, patients experiencing multiple SAEs of the same type are included only once per type of SAE
^^Myocardial infarction and embolic stroke are included in thromboembolic SAEs