72 PART TWO | CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING acute/delayed phases were also evaluated as secondary endpoints. Safety was assessed by collection of side effects associated with DEX (evaluated with DSQ), and by collection of metoclopramide-associated dyskinesias (evaluated with AIMS). Statistical analysis Assuming a delayed TC rate of 80% in the 3-day DEX arm and 60% in the 1-day DEX arms (19) with a noninferiority margin set at -20%, a total of 189 patients (63 patients per arm) were required under a two-sided 5% significance level and 80% power, to show the noninferiority of the MCP and PAL arm to the DEX arm. Allowing a dropout rate of 20%, we aimed to enroll 237 patients (79 patients per arm). Number and proportion of patients with delayed TC was reported for each treatment group, and 95% confidence interval (CI) was estimated. If the lower limit of the 95% CI of the difference in delayed TC rates between the MCP and DEX arm or between the PAL and DEX arm was greater than the noninferiority margin of -20%, we would conclude that the MCP and PAL arms were noninferior to the DEX arm with regard to delayed TC. Because failure to control acute nausea and vomiting on the first day of chemotherapy will increase the risk of delayed nausea and vomiting (26), a bootstrap approach for analysis of covariance (ANCOVA) with a Bonferroni correction (Bonferroni post hoc test) was used to test the effect of antiemetic study medication on delayed TC, controlling for the effect of acute TC (covariate) on delayed TC rates. For secondary endpoints, statistical analyses utilized the same methods as the primary endpoint. Baseline characteristics were compared between the treatment arms with the Mann-Whitney U test or chi-squared test. A P-value ≤0.05 was considered statistically significant. All analyses were conducted by using IBM SPSS statistics version 22 (Chicago, IL, United States).
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