Table 6.
Overview of adverse events.
| Number (%) of patients with the following | Cycle 1 | All cycles* | ||||
|---|---|---|---|---|---|---|
| NEPA + DEX (N = 1442) | IV or oral PALO + DEX (N = 1600) | APR + OND/PALO + DEX (N = 238) | NEPA + DEX (N = 1033) | Oral PALO + DEX (N = 725) | APR + oral PALO + DEX (N = 104) | |
| Any treatment-emergent AE (TEAE) | 944 (65.5%) | 945 (59.1%) | 135 (56.7%) | 1127 (78.2%) | 1080 (67.5%) | 166 (69.7%) |
|
| ||||||
| Treatment-related AE (TRAE) | 138 (9.6%) | 105 (6.6%) | 29 (12.2%) | 194 (13.5%) | 134 (8.4%) | 32 (13.4%) |
|
| ||||||
| Serious TEAE | 33 (2.3%) | 87 (5.4%) | 4 (1.7%) | 87 (6.0%) | 99 (6.2%) | 19 (8.0%) |
|
| ||||||
| Serious TRAE | 2 (0.1%) | 2 (0.1%) | — | 3 (0.2%) | 2 (0.1%) | — |
|
| ||||||
| TEAE leading to death | 8 (0.6%) | 20 (1.3%) | — | 17 (1.2%) | 21 (1.3%) | 1 (0.4%) |
|
| ||||||
| TEAE leading to discontinuation | 14 (1.0%) | 6 (0.4%) | 4 (1.7%) | 44 (3.1%) | 20 (1.3%) | 13 (5.5%) |
|
| ||||||
| TRAE leading to discontinuation | 2 (0.1%) | 2 (0.1%) | — | 1 (0.1%) | 4 (0.3%) | — |
*All cycles: Cycle 1 from all Phase 2/3 studies + Cycles 2 and beyond from the Phase 3 multiple cycle trials.
Treatment-emergent adverse event (TEAE): any AE reported after first study drug intake.
TRAE: AEs deemed possibly, probably, or definitely related to study drug.
DEX: dexamethasone, PALO: palonosetron, and APR: aprepitant.