Primary outcome measure
pneumonia
ADVERSE EVENTS, WOUND DEHISCENCE, PNEUMONIA, URINARY TRACT INFECTION
During the study period, a total of 62 AEs was observed. Merely two (3.2%) cases of superficial surgical site infection (grade II based on CTCAE version 4) and wound dehiscence (grade I) in cohort 2 were attributable to the study intervention (surgical procedure), that were treated successfully. The other 60 (96.8%) cases, including 39 grade I (62.9%), 19 grade II (30.6%), and 2 grade III (3.2%) AEs were not related to the study intervention. The observed grade III AEs were not attributable to the study intervention and included one case of urinary tract infection (1.6%) and one case of pneumonia (1.6%). No DLT was observed in any of the study cohorts. The dose escalation was proceeded to the maximum planned study dose (cohort 3, 10 × 10
All adverse events observed during the study period