TABLE 2.
Grade 3 or Greater Treatment-Emergent Adverse Events Occurring in 5% or More of Participants (SAF population)
| Adverse Event | Gilteritinib (n = 178) | Placebo (n = 177) | Total (n = 355) |
|---|---|---|---|
| No. of Patients (%) | |||
| Hematologic | |||
| Neutrophil count decreased | 64 (36) | 23 (13) | 87 (24.5) |
| Platelet count decreased | 38 (21.3) | 20 (11.3) | 58 (16.3) |
| Anemia | 17 (9.6) | 14 (7.9) | 31 (8.7) |
| WBC count decreased | 18 (10.1) | 3 (1.7) | 21 (5.9) |
| Nonhematologic | |||
| ALT increased | 11 (6.2) | 8 (4.5) | 19 (5.4) |
| AST increased | 11 (6.2) | 6 (3.4) | 17 (4.8) |
| Hypertension | 11 (6.2) | 6 (3.4) | 17 (4.8) |
| Creatine phosphokinase elevation | 14 (7.9) | 1 (0.6) | 15 (4.2) |
Abbreviation: SAF, safety analysis set.