Table 4.
Patients with adverse events.
| Variable (N (%)) | Cohort 1 (n = 59) | Cohort 2 (n = 260) | Cohort 3 (n = 30) | Total (n = 349) |
|---|---|---|---|---|
| Number of patients with at least one AE | 9 (15.3%) | 68 (26.2%) | 7 (23.3%) | 84 (24.1%) |
| Number of deaths | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Number of patients with at least one serious AE | 0 (0.0%) | 7 (2.7%) | 0 (0.0%) | 7 (2.0%) |
| Number of patients with at least one AE leading to discontinuation | 6 (10.2%) | 40 (15.4%) | 4 (13.3%) | 50 (14.3%) |
| Number of patients with at least one severe AE | 0 (0.0%) | 6 (2.3%) | 0 (0.0%) | 6 (1.7%) |
| Number of patients with at least one ADR | 9 (15.3%) | 46 (17.7%) | 6 (20.0%) | 61 (17.5%) |
| Number of patients with at least one serious ADR | 0 (0.0%) | 2 (0.8%) | 0 (0.0%) | 2 (0.6%) |
| Number of patients with at least one severe ADR | 0 (0.0%) | 2 (0.8%) | 0 (0.0%) | 2 (0.6%) |
AE = adverse event; ADR = adverse drug reaction.