Table 2.
Efficacy endpoints
| Primary analyses (NEPA versus PALO) |
Exploratory analysis APR versus PALO |
||||
|---|---|---|---|---|---|
| PALO (N = 136) | NEPA100 (N = 135) | NEPA200 (N = 137) | NEPA300 (N = 135) | APR + OND (N = 134) | |
| Complete response (%) | |||||
| Acute (0–24 h) | 89.7 | 93.3 | 92.7 | 98.5%† | 94.8 |
| Delayed (25–120 h) | 80.1 | 90.4* | 91.2† | 90.4* | 88.8‡ |
| Overall (0–120 h) | 76.5 | 87.4* | 87.6* | 89.6† | 86.6‡ |
| No emesis (%) | |||||
| Acute | 89.7 | 93.3 | 92.7 | 98.5† | 94.8 |
| Delayed | 80.1 | 90.4* | 91.2† | 91.9† | 89.6‡ |
| Overall | 76.5 | 87.4* | 87.6* | 91.1† | 87.3‡ |
| No significant nausea (%) | |||||
| Acute | 93.4 | 94.1 | 94.2 | 98.5* | 94.0 |
| Delayed | 80.9 | 81.5 | 89.8* | 90.4† | 88.1 |
| Overall | 79.4 | 80.0 | 86.1 | 89.6* | 85.8 |
| Complete protection (%) | |||||
| Acute | 87.5 | 89.6 | 88.3 | 97.0† | 89.6 |
| Delayed | 73.5 | 80.0 | 87.6† | 84.4* | 82.1 |
| Overall | 69.9 | 76.3 | 80.3* | 83.0† | 78.4 |
†P ≤ 0.01 from logistic regression versus palonosetron; not adjusted for multiple comparisons, with exception of primary endpoint (CR overall).
*P ≤ 0.05 from logistic regression versus palonosetron; not adjusted for multiple comparisons, with exception of primary endpoint (CR overall).
‡P ≤ 0.05 from post hoc logistic regression versus palonosetron.