A Review of NEPA, a Novel Fixed Antiemetic Combination with the Potential for Enhancing Guideline Adherence and Improving Control of Chemotherapy-Induced Nausea and Vomiting
Table 6
Overview of adverse events.
Number (%) of patients with the following
Cycle 1
All cycles*
NEPA + DEX ()
IV or oral PALO + DEX ()
APR + OND/PALO + DEX ()
NEPA + DEX ()
Oral PALO + DEX ()
APR + oral PALO + DEX ()
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.
