Table 3.
Adverse events of special interest (AESIs) occurring between Day 29 and Month 3 (Safety Analysis set).
| AESIs occurring between Day 29 and Month 3 |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 AESI | 0 (0) | 0 | 3 (50) | 3 | 0 (0) | 0 | 0 (0) | 0 | 2 (25) | 2 | 5 (25) | 5 |
| Leading to death | 0 (0) | 0 | 2 (33) | 2 | 0 (0) | 0 | 0 (0) | 0 | 1 (12) | 1 | 3 (12) | 3 |
| Liver transplant | 0 (0) | 0 | 1 (17) | 1 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (8) | 1 |
| Hospitalisation | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (12) | 1 | 1 (8) | 1 |
n (%), number (percentage) of patients. NoE, number of events.