Table 4:
Common (≥ 10% any-grade, ≥ 5% Grade 3–5) Treatment-emergent Adverse Reactions in the Preselected Low Intensity Chemotherapy Subgroup in the First 30 Days of the ADMIRAL trial Safety Populationa
| Gilteritinib (N=97) | Chemotherapy (N=41) | |||
|---|---|---|---|---|
| Adverse reactionb | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 |
| Transaminase increased | 36% | 9% | 15% | 2% |
| Febrile neutropenia | 27% | 26% | 12% | 12% |
| Myalgia/arthralgia | 22% | 2% | 17% | 0 |
| Fatigue/malaise | 21% | 4% | 22% | 2% |
| Edema | 20% | 1% | 12% | 0 |
| Mucositis | 20% | 1% | 17% | 2% |
| Constipation | 13% | 1% | 12% | 0 |
| Diarrhea | 12% | 0 | 5% | 0 |
| Dyspnea | 11% | 3% | 5% | 5% |
| Fever | 11% | 0 | 17% | 0 |
| Nausea | 10% | 0 | 17% | 0 |
| Rash | 10% | 2% | 5% | 0 |
a
N = 138 adults with R/R AML treated with gilteritinib or low intensity chemotherapy.
b
Includes grouped terms. See Supplementary Table S2 for further information.