| Day 1 - 4 | Day 5 - 30 | Day 30 - 90 |
|
| |
| Total | 14 (36%) | 16 (41%) | 19 (49%) |
|
|
| Grade I/II |
|
|
|
|
|
| Pain | 7 (18%) | 3 (8%) | 2 (5%) |
|
|
| Nausea | 4 (10%) | 7 (18%) | 5 (13%) |
|
|
| Fatigue | 0 | 6 (15%) | 5 (13%) |
|
|
| Ascites | 0 | 1 (3%) | 10 (26%) |
|
|
| Encephalopathy | 0 | 1 (3%) | 2 (5%) |
|
|
| Fever | 2 (5%) | 0 | 0 |
|
|
| Hypotension | 2 (5%) | 0 | 0 |
|
|
| Pruritus | 1 (3%) | 1 (3%) | 1 (3%) |
|
|
| Grade III |
|
|
|
|
|
| Cholangitis | 1 (3%) | 0 | 0 |
|
|
| Pancreatitis | 0 | 1 (3%) | 0 |
|
|
| Renal failure | 0 | 0 | 1 (3%) |
|
|
| Anemia | 0 | 0 | 1 (3%) |
|
|
| Total treatment emergent adverse events by type of microsphere: |
|
|
|
|
|
| Theraspheres© (n = 23) | 9 (39%) | 10 (43%) | 12 (52%) |
|
|
| SIRT-Spheres© (n = 16) | 5 (31%) | 6 (38%) | 7 (44%) |
|
|