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.