Grade ≥ 3 adverse events | 2019 study (n = 172) (%) | Phase II ANNOUNCE (n = 64) (%) | Phase III ANNOUNCE (n = XX) (%) |
---|---|---|---|
All Grade ≥ 3 AEs | 82 (47.7%) | 51 (79.7%) | Unknown |
Anaemia | 21 (12.2%) | 8 (12.5%) | Unknown |
Neutropaenia | 57 (33.1%) | 34 (53.2%) | 48% |
Neutropaenic fever | 7 (4.1%) | 8 (12.5%) | Unknown |
Thrombocytopaenia | 3 (1.7%) | Unknown | 6% |
Hepatotoxicity | 2 (1.2%) | Unknown | Unknown |
Oral mucositis | 6 (3.5%) | 2 (3.1%) | 3% |
Diarrhoea | 3 (1.7%) | 2 (3.1%) | 3% |
Nausea | 2 (1.2%) | 1 (1.6%) | 2% |
Vomiting | 3 (1.7%) | 0 (0%) | 0% |
Fatigue | 3 (1.7%) | 6 (9.4%) | 9% |
Cardiac toxicity | 6 (3.5%)a | 1 (1.6%) | Unknown |
Sepsis | 13 (7.6%) | 5 (7.8%) | Unknown |