74 PART TWO | CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING Baseline characteristics of all randomized patients are summarized in supplemental Table S2. Post-randomization, 42 patients (n = 17 DEX arm, n = 13 MCP arm, n = 12 PAL arm) did not complete any study assessments, and were therefore excluded from efficacy and safety analyses. Consequently, 189 patients (n = 60 DEX arm, n = 66 MCP arm, n = 63 PAL arm) represented the efficacy and safety population. Baseline characteristics of these patients were similar between treatment groups (Table 1). Slightly more patients were male (53.4%); colorectal cancer was the most common type of cancer (85.7%); oxaliplatin-based chemotherapy (81.5%) was the most commonly prescribed chemotherapeutic regimen. Table 1. Patient baseline and disease characteristics (efficacy and safety population). All patients (n = 189), n(%) DEX arm (n = 60), n(%) MCP arm (n = 66), n(%) PAL arm (n = 63), n(%) Age (years) Median (range) ≤55 years >55 years 65.0 (40-84) 30 (15.9) 159 (84.1) 64.0 (46-82) 9 (15.0) 51 (85.0) 65.0 (40-84) 14 (21.2) 52 (78.8) 67.0 (40-82) 7 (11.1) 56 (88.9) Gender Male Female 128 (55.7) 102 (44.3) 32 (53.3) 28 (46.7) 34 (51.5) 32 (48.5) 35 (55.6) 28 (44.4) Tumor type Colorectal Ovarian Lung Gastric Pancreatic Other 162 (85.7) 13 (6.9) 6 (3.2) 4 (2.1) 3 (1.6) 1 (0.5) 53 (88.3) 4 (6.6) 1 (1.7) 1 (1.7) 1 (1.7) 0 (0) 54 (81.8) 5 (7.6) 4 (6.1) 2 (3.0) 1 (1.5) 0 (0) 55 (87.3) 4 (6.3) 1 (1.6) 1 (1.6) 1 (1.6) 1 (1.6) Chemotherapy Oxaliplatin-baseda Carboplatin-basedb Irinotecan-based Anthracycline-basedc Other 154 (81.5) 19 (10) 11 (5.8) 4 (2.1) 1 (0.6) 52 (86.7) 5 (8.3) 2 (3.3) 1 (1.7) 0 (0.0) 50 (75.8) 9 (13.6) 5 (7.6) 2 (3.0) 0 (0.0) 52 (82.5) 5 (7.9) 4 (6.4) 1 (1.6) 1 (1.6) Abbreviations: DEX, 3-day dexamethasone; MCP, metoclopramide; PAL, palonosetron aOxaliplatin dose: 130 mg/m2 bCarboplatin dose: area under the curve (AUC) ≥4 mg/mL/minute (recently reclassified as highly emetogenic) cEpirubicin dose: 50 mg/m2 Efficacy Delayed TC rates were 50.0% (95% CI: 36.8, 63.2) in the DEX arm, 56.1% (95% CI: 43.3, 68.3) in the MCP arm, and 55.6% (95% CI: 42.5, 68.1) in the PAL arm (Figure 2). The 95% CI of the difference in delayed TC rates between the MCP and DEX arm was-11.3% to 23.5%; between the PAL and DEX arm-12.0% to 23.2%, both meeting the criteria for noninferiority to the DEX arm. TC rates in the acute phase were 85.0% (95% CI: 73.4%, 92.9%) in the DEX arm, 90.9% (95% CI: 81.3%, 96.6%) in the MCP arm, and 79.4% (95%
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