Safety Profile
The safety profile of ZELVARA was evaluated in 538 patients who received ZELVARA plus chemotherapy across the BEACON-1 and BEACON-2 trials.
Warning: Nausea and Vomiting
ZELVARA can cause severe nausea and vomiting. Administer antiemetic prophylaxis prior to and during treatment with ZELVARA. Withhold, dose reduce, or permanently discontinue ZELVARA based on severity.
Grade 3+ TEAEs
86%
vs 77%
Serious AEs
42%
vs 35%
Discontinuation
15.2%
vs 8.4%
Fatal AEs
2.1%
vs 1.8%
27 of 27 events
| Adverse Event ↕ | ZELVARA + Chemo All Grades ↓ | Placebo + Chemo All Grades ↕ | Delta ↕ |
|---|---|---|---|
| NauseaGI | 70.2% | 48.5% | +21.7% |
| VomitingGI | 64.8% | 29.4% | +35.4% |
| Decreased appetiteConstitutional | 42.1% | 32.6% | +9.5% |
| FatigueConstitutional | 38.4% | 34.1% | +4.3% |
| NeutropeniaHematologic | 34.2% | 32.8% | +1.4% |
| DiarrheaGI | 28.7% | 24.3% | +4.4% |
| AnemiaHematologic | 28.4% | 26.2% | +2.2% |
| Peripheral neuropathyNeurologic | 22.5% | 20.8% | +1.7% |
| Weight decreasedConstitutional | 19.1% | 14.2% | +4.9% |
| ThrombocytopeniaHematologic | 18.6% | 16.4% | +2.2% |
| ConstipationGI | 18.4% | 16.8% | +1.6% |
| Abdominal painGI | 16.2% | 14.8% | +1.4% |
| AST increasedHepatic | 14.8% | 12.2% | +2.6% |
| DehydrationConstitutional | 14.5% | 6.2% | +8.3% |
| LeukopeniaHematologic | 14.2% | 13.1% | +1.1% |
| HypokalemiaMetabolic | 12.4% | 8.1% | +4.3% |
| ALT increasedHepatic | 12.4% | 10.6% | +1.8% |
| StomatitisGI | 12.1% | 10.2% | +1.9% |
| PyrexiaConstitutional | 10.8% | 8.4% | +2.4% |
| HypoalbuminemiaMetabolic | 10.1% | 8.8% | +1.3% |
| Edema peripheralOther | 9.4% | 8.2% | +1.2% |
| DizzinessNeurologic | 8.4% | 7.2% | +1.2% |
| AlopeciaDermatologic | 8.4% | 7.8% | +0.6% |
| HypomagnesemiaMetabolic | 8.2% | 5.4% | +2.8% |
| DysgeusiaNeurologic | 7.8% | 6.4% | +1.4% |
| Infusion-related reactionOther | 6.8% | 1.4% | +5.4% |
| Palmar-plantar erythrodysesthesiaDermatologic | 6.2% | 5.8% | +0.4% |
Treatment Discontinuation Due to Adverse Events
| Reason | ZELVARA + Chemo | Placebo + Chemo |
|---|---|---|
| Any adverse event | 15.2% | 8.4% |
| Nausea | 3.8% | 0.4% |
| Vomiting | 3.2% | 0.2% |
| Decreased appetite | 1.8% | 0.6% |
| Fatigue | 1.4% | 0.8% |
| Dehydration | 1.2% | 0.2% |
| Infusion-related reaction | 0.8% | 0% |
Safety population: ZELVARA + chemotherapy (n=538), Placebo + chemotherapy (n=537). Combined data from BEACON-1 and BEACON-2.