Table 2.
Treatment-emergent adverse events
| Patients, n (%) | Treated patients, n = 53 |
|---|---|
| ≥ 1 reported TEAE | 45 (84.9) |
| Considered treatment-related | 3 (5.7) |
| ≥ 1 SAE | 21 (39.6) |
| Considered treatment-related | 0 |
| ≥ 1 severe TEAE | 17 (32.1) |
| Considered treatment-related | 0 |
| Discontinued study due to TEAE* | 1 (1.9) |
| Considered treatment-related | 0 |
| With ≥ 1 dosing interruption due to TEAEs | 3 (5.7) |
| Considered treatment-related | 1 (1.9) |
| With study drug withdrawal due to a TEAE | 1 (1.9) |
| Considered treatment-related | 0 |
| With a TEAE leading to death | 6 (11.3) |
| Considered treatment-related | 0 |
SAE serious treatment-emergent adverse event, TEAE treatment-emergent adverse event
*Except death