Table 2.
Adverse events (AEs) occurring during the first 28 days of the study (Safety Analysis set).
| AEs occurring during the active study period (within 28 days after HALPC infusion) |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 (N = 3) |
Cohort 2 (N = 6) |
Cohort 3 (N = 3) |
Cohort 4 (N = 4) |
Cohort 5 (N = 8) |
Total (N = 24) |
|||||||
| n (%) | NoE | n (%) | NoE | n (%) | NoE | n (%) | NoE | n (%) | NoE | n (%) | NoE | |
| Any AE | 3 (100) | 11 | 6 (100) | 46 | 1 (33) | 1 | 4 (100) | 23 | 7 (88) | 40 | 21 (88) | 121 |
| Related to HALPC therapy | 2 (67) | 4 | 2 (33) | 2 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 4 (17) | 6 |
| Related to study procedure | 2 (67) | 4 | 1 (17) | 1 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 3 (12) | 5 |
| Leading to study stop | 2 (67) | 4 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 2 (8) | 4 |
| Any severe AE | 3 (100) | 5 | 3 (50) | 9 | 0 (0) | 0 | 2 (50) | 2 | 3 (38) | 9 | 11 (46) | 25 |
| Any serious AE | 3 (100) | 5 | 3 (50) | 7 | 0 (0) | 0 | 1 (25) | 1 | 3 (38) | 5 | 10 (42) | 18 |
| Related to HALPC therapy | 2 (67) | 4 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 2 (8) | 4 |
| Related to study procedure | 2 (67) | 4 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 2 (8) | 4 |
| Leading to study stop | 2 (67) | 4 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 2 (8) | 4 |
| Leading to death | 1 (33) | 1 | 0 (0) | 0 | 0 (0) | 0 | 1 (25) | 0 | 2 (25) | 2 | 4 (17) | 4 |
n (%), number (percentage) of patients. HALPC, human allogeneic liver-derived progenitor cells; NoE, number of events.