Table 3 Adverse Events (Safety Population)
|  |  | Dose level 1 |  | Dose level − 1 |  | Total |  |  | ||
|---|---|---|---|---|---|---|---|---|---|---|
|  | Number of Patients with... | (N = 3) |  | nEvents | (N = 6) |  | nEvents | (N = 9) |  | nEvents |
| Â | at least one AE | 3 | (100.00%) | 141 | 6 | (100.00%) | 247 | 9 | (100.00%) | 388 |
| Â | SAEs | 2 | (66.67%) | 6 | 5 | (83.33%) | 13 | 7 | (77.78%) | 19 |
| Â | Related AEs | 3 | (100.00%) | 102 | 6 | (100.00%) | 137 | 9 | (100.00%) | 239 |
| Â | AEs leading to premature study discontinuation | 0 | (0.00%) | 0 | 1 | (16.67%) | 1 | 1 | (11.11%) | 1 |
| Â | AEs leading to death | 1 | (33.33%) | 2 | 1 | (16.67%) | 1 | 2 | (22.22%) | 3 |