Table 2.
Complete response (defined as no emetic episodes and no use of rescue medication) rates in the study cohorts
| Complete responses | ||||
|---|---|---|---|---|
| Palo plus 1-day Dexa (n (%)) | Palo plus 3-day Dex (n (%)) | Difference between groupsb (95% CI), % | P c | |
| ITT cohortd, n = 332 | n = 166 | n = 166 | ||
| Acute phase (0–24 h) | 147 (88.6) | 140 (84.3) | 4.2 (−3.1 to 11.6) | 0.262 |
| 95% CI | 82.7 to 92.9 | 77.9 to 89.5 | ||
| Delayed phase (24–120 h) | 114 (68.7) | 129 (77.7) | −9.0 (−18.5 to 0.4) | 0.116 |
| 95% CI | 61.0 to 75.6 | 70.6 to 83.8 | ||
| Overall phasee (0–120 h) | 112 (67.5) | 118 (71.1) | −3.6 (−13.5 to 6.3) | ND |
| 95% CI | 59.8 to 74.5 | 63.6 to 77.9 | ||
| PP cohortf, n = 324 | (n = 163) | (n = 161) | ||
| Acute phase (0–24 h) | 144 (88.3) | 135 (83.9) | 4.5 (−3 to 12) | 0.242 |
| 95% CI | 82.4 to 92.8 | 77.2 to 89.2 | ||
| Delayed phase (24–120 h) | 112 (68.7) | 124 (77.0) | −8.3 (−17.9 to 1.3) | 0.093 |
| 95% CI | 60.9 to 75.7 | 69.7 to 83.3 | ||
| Overall phasee (0–120 h) | 109 (66.9) | 113 (70.2) | −3.3 (−13.4 to 6.8) | ND |
| 95% CI | 59.1 to 74.0 | 62.5 to 77.1 | ||
ND not done
aPalonosetron plus dexamethasone
b1-day minus 3-day regimen with 95% confidence interval obtained using normal approximation of binomial data
cTwo-sided chi-square test (1-day vs. 3-day)
dIntention-to-treat
eNon-inferiority hypothesis in primary analysis was proven as the lower boundaries of the 95% CI of between-group difference were greater than the preset threshold (−15%)
fPer-protocol cohort