Safety results
post-ESD coagulation syndrome, fever, abdominal pain
ADVERSE REACTIONS, INFLAMMATION, ADVERSE EVENTS
The AE incidence rate was 39.6% in the TDM-621 group and 37.6% in the control group, with no significant differences between the groups. The incidence rate of adverse reactions was 1.0% in the TDM-621 group, and no adverse reactions were observed in the control group. No defects derived from TDM-621 occurred in any patients.Table Frequency of adverse events based on CTCAE in either group (SP)Regarding symptoms of post-ESD coagulation syndrome, such as fever, localized abdominal pain, and inflammation, several cases were observed in both the control and TDM-621 groups; however, there was no significant difference in the incidence between the 2 groups.