Safety
Discontinuations, TEAEs
ADVERSE EVENT
Overall, the incidence of TEAEs and study‐drug related TEAEs was similar between the two treatment arms. The proportion of patients who experienced at least one TEAE was 97.2% in the BAT1706 arm and 98.1% in the EU‐bevacizumab arm (Table Summary of TEAEs of all causalities—safety population.Abbreviations: LTE, long‐term extension; TEAE, treatment‐emergent adverse event.




TEAEs of Grade ≥3 were reported by 218 (67.1%) patients in the BAT1706 arm and 235 (72.5%) in the EU‐bevacizumab arm; TEAEs of Grade ≥4 were reported by 92 (28.3%) patients in in the BAT1706 arm and 93 (28.7%) in the EU‐bevacizumab arm. In total, 35 (5.4%) patients died due to a TEAE (18 patients in the BAT1706 arm and 17 in the EU‐bevacizumab arm). Among these, 11 (1.7%) patients died due to a TEAE that was considered by the investigator to be related to BAT1706 (eight patients) or EU‐bevacizumab (three patients), and a similar number of patients (12 patients; 1.8%) died due to a TEAE that was considered by the investigator to be related to carboplatin or paclitaxel. TEAEs that led to discontinuation of treatment were reported by 53 (8.2%) patients (28 patients in the BAT1706 arm and 25 in the EU‐bevacizumab arm). Discontinuations considered by investigators to be related to BAT1706/EU‐bevacizumab and paclitaxel/carboplatin were similar in both arms.