76 PART TWO | CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING Table 2. Secondary efficacy endpoints. Endpoint DEX arm (n = 60), % MCP arm (n = 66), % PAL arm (n = 63), % MCP-DEX risk difference (95% CI) PAL-DEX risk difference (95% CI) No vomiting Acute Delayed Overall 95.0% 88.3% 83.3% 97.0% 77.3% 75.8% 88.9% 77.8% 74.6% 2.0% (-4.9%, 8.9%) -11% (-24.0%, 2.0%) -7.5% (-21.5%, 6.5%) -6.1% (-15.6%, 3.4%) -10.5% (-23.6%, 2.6%) -8.7% (-23.0%, 5.6%) No significant nausea Acute Delayed Overall 90.0% 73.3% 70.0% 93.9% 71.2% 68.2% 85.7% 66.7% 63.5% 3.9% (-5.6%, 13.4%) -2.1% (-17.7%, 13.5%) -1.8% (-18.0%, 14.4%) -4.3% (15.8%, 7.2%) -6.6% (-22.8%, 9.6%) -6.5% (-23.1%, 10.1%) No nausea Acute Delayed Overall 63.3% 48.3% 45.0% 75.8% 43.9% 39.4% 69.8% 50.8% 46.0% 12.5% (-4.9%, 29.9%) -4.4% (-21.7%, 12.9%) -5.6% (-22.9%, 11.7%) 6.5% (-11.2%, 24.2%) 2.5% (-15.1%, 20.1%) 1.0% (-16.6%, 18.6%) No rescue use Acute Delayed Overall 91.7% 63.3% 60.0% 97.0% 72.7% 69.7% 88.9% 73.0% 71.4% 5.3% (-12.1%, 22.7%) 9.4% (6.9%, 25.7%) 9.7% (6.9%, 26.3%) -2.8% (-20.8%, 14.9%) 9.7% (-6.7%, 26.1%) 11.4% (-5.3%, 28.1%) CR Acute Delayed Overall 91.7% 55.0% 51.7% 93.9% 60.6% 56.1% 82.5% 66.7% 63.5% 2.2 (-8.5%, 12.9%) 5.6 (-11.7%, 22.9%) 4.4 (-13.0%, 21.8%) -9.2 (-21.1%, 2.70%) 11.7 (-5,4%, 28.8%) 11.8 (-5.6%, 29.2%) CP Acute Delayed Overall 85.0% 50.0% 46.7% 90.9% 56.1% 51.5% 79.4% 55.6% 54.0% 5.9 (-5.8%, 17.3%) 6.1 (-11.3%, 23,5%) 4.8 (-12.7%, 22.3%) -5.6 (-17.9%, 6.7%) 5.6 (-12.0%, 23.2%) 7.3 (-10.3%, 24.9%) Abbreviations: CI, confidence interval, CP, complete protection; CR, complete response; DEX, 3-day dexamethasone; MCP, metoclopramide; PAL, palonosetron No vomiting, no significant nausea, and no nausea rates during the delayed phase were slightly higher in the DEX arm; no use of rescuemedication and delayed CR ratewere higher in the PAL arm; delayed CP rate favored the MCP arm. All differences were not statistically significant between treatment arms. On day 2, mean FLIE score in the DEX arm was 118 (Standard Deviation, SD, 17.5), 117 (SD, 22.4) in the MCP arm, and 114 (SD, 21.7) in the PAL arm. Slightly more patients in the MCP arm reported NIDL (87.5%), compared with 86.0% in the DEX arm, and 78.7% in the PAL arm (Figure 3).
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