Sample size and statistical analysis
SECONDARY, ADVERSE REACTIONS
The mean number of coagulations during ESD with hemostatic forceps (the primary efficacy end point) was assumed to be 3.1 in the control group and 2.1 in the TDM-621 group, based on our pilot study. Based on this assumed mean value, simulated data were created using random numbers according to a Poisson distribution. The required number of patients in each group, calculated with a simulation (1,000 times) to ensure equality of distribution in the 2 groups using a Wilcoxon rank sum test (detection power of 80% at the significance level), was 44. The SD of the total number of cauterizations was 2.3, while the SD in the Poisson distribution (mean value of 3.1) was 1.76. When the SD was 1.3, the required sample size was approximately 1.52; thus, the required sample size was adjusted to 80 patients in each group.The primary, secondary, and other end points for efficacy were analyzed with the per protocol set (PPS) that represented compliance with the protocol. For the total number of cauterizations per patient treated with hemostatic forceps, a summary statistic (number of patients, mean, SD, median, minimum, maximum) was calculated. Superiority was confirmed with a significance level of 5% on both sides by comparing the groups using the Wilcoxon rank sum test. The number of cauterizations according to the operator's judgment was analyzed similarly to the primary efficacy end point. For other end points, summary statistics were calculated, and the Wilcoxon rank sum and Fisher exact tests were performed for intergroup comparisons. Safety was analyzed for the safety population (SP) and replaced as the lowest level term based on MedDRA/J version 22.1. Adverse reactions were classified with the system organ class and preferred terms and calculated using 95% confidence intervals. The Fisher exact test was used to compare the incidence rate between the groups, and statistical significance was set at 