Table 3. AEs, grade ≥3 AEs (based on AEs of any grade with an incidence of ≥20%), and SAEs (based on SAEs of any grade with an incidence of >1 patient) (safety population).

Data are presented as n (%).

^aFatal AEs: pneumonia (three patients), intestinal obstruction (one patient). Other fatal AEs were meningitis (one patient) and septic shock (one patient).

Abbreviations: AE, adverse event; SAE, serious adverse event.