Summary of AEs in the FAS
| AE, n (%) | FAS (n = 294) |
|---|---|
| Any AEs | 117 (39.8) |
| Treatment-emergent AEs (TEAEs) | 109 (37.1) |
| Adverse drug reactions (ADRs) | 22 (7.5) |
| AEs with CTCAE grade ≥ 3 | 32 (10.9) |
| TEAEs with CTCAE grade ≥ 3 | 31 (10.5) |
| Serious AEs | 30 (10.2) |
| Serious TEAEs | 30 (10.2) |
| Treatment-related serious TEAEs | 1 (0.3) |
| TEAEs leading to death | 1 (0.3) |
| TEAEs leading to treatment discontinuation | 1 (0.3) |
| ADRs leading to treatment discontinuation | 0 |
| AEs of interest (cardiovascular, sexual) | 0 |
AE, adverse event; CTCAE, common terminology criteria for adverse events; TEAE, treatment-emergent adverse event.