75 4 CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING | PART TWO CI: 67.3%, 88.5%) in the PAL arm. The 95% CI of the difference in acute TC rates was-5.6% to 17.0% between the MCP and DEX arm, and-19.2% to 7.6% between the PAL and DEX arm. In the overall phase, TC rates were 46.7% (95% CI: 33.7%, 60.0%) in the DEX arm, 54.0% (95% CI: 40.9%, 66.6%) in the MCP arm, and 51.5% (95% CI: 38.9%, 64.0%) in the PAL arm. The 95% CI of the difference in overall TC rates was-10.3% to 24.9% between the MCP and DEX arm, and-12.7% to 22.3% between the PAL and DEX arm. After controlling for acute TC as covariate, we found no significant differences between the DEX arm and both the MCP (p = 0.68) and PAL arm (p = 0.35). Figure 2. Noninferiority hypothesis in primary analysis was proven as the lower boundaries of the 95% CI of between-group difference were greater than the preset threshold (−20%). Abbreviations: CI, confidence interval; DEX, 3-day dexamethasone; MCP, metoclopramide; PAL, palonosetron Response rates for all secondary efficacy endpoints during the acute phase favored the MCP arm, although differences were not statistically significant between treatment arms. (Table 2).
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