Table 3. Summary of most common treatment-emergent AEsa.
| AE, n (%) |
Fedratinib |
|||||||
|---|---|---|---|---|---|---|---|---|
|
300 mg (n=10) |
400 mg (n=10) |
500 mg (n=11) |
Total (n=31) |
|||||
| All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | |
| Nonhematologic AEs | ||||||||
| Fatigue | 8 (80) | 3 (30) | 7 (70) | 1 (10) | 8 (73) | 0 | 23 (74) | 4 (13) |
| Diarrhea | 7 (70) | 1 (10) | 9 (90) | 2 (20) | 9 (82) | 1 (9) | 25 (81) | 4 (13) |
| Nausea | 7 (70) | 1 (10) | 7 (70) | 1 (10) | 10 (91) | 0 | 24 (77) | 2 (6) |
| Vomiting | 6 (60) | 2 (20) | 7 (70) | 1 (10) | 8 (80) | 0 | 21 (68) | 3 (10) |
| Constipation | 2 (20) | 0 | 4 (40) | 0 | 3 (27) | 0 | 9 (29) | 0 |
| Peripheral edema | 4 (40) | 0 | 4 (40) | 1 (10) | 3 (27) | 0 | 11 (35) | 1 (3) |
| Dyspnea | 2 (20) | 0 | 4 (40) | 1 (10) | 3 (27) | 0 | 9 (29) | 1 (3) |
| Pain in extremity | 2 (20) | 1 (10) | 3 (30) | 0 | 2 (18) | 0 | 7 (23) | 1 (3) |
| Infections | 2 (20) | 0 | 3 (30) | 2 (20) | 6 (55) | 4 (36) | 11 (35) | 6 (19) |
| Hematologic AEsb | ||||||||
| Anemia | 10 (100) | 6 (60) | 10 (100) | 5 (50) | 11 (100) | 7 (64) | 31 (100) | 18 (58) |
| Thrombocytopenia | 5 (50) | 2 (20) | 5 (50) | 1 (10) | 7 (64) | 2 (18) | 17 (55) | 5 (16) |
| Leukopenia | 3 (30) | 1 (10) | 1 (10) | 0 | 5 (45) | 0 | 9 (29) | 1 (3) |
| Laboratory parameters | ||||||||
| ALT | 3 (30) | 1 (10) | 5 (50) | 0 | 10 (91) | 1 (9) | 18 (58) | 2 (6) |
| AST | 4 (40) | 1 (10) | 8 (80) | 0 | 10 (91) | 1 (9) | 22 (67) | 2 (6) |
| Bilirubin | 3 (30) | 1 (10) | 4 (40) | 0 | 3 (27) | 0 | 10 (32) | 1 (3) |
| Creatinine | 5 (50) | 0 | 6 (60) | 0 | 8 (73) | 0 | 19 (61) | 0 |
| Amylase | 4 (40) | 0 | 3 (30) | 0 | 5 (45) | 0 | 12 (39) | 0 |
| Lipase | 4 (40) | 2 (20) | 7 (70) | 2 (20) | 6 (55) | 2 (18) | 17 (55) | 6 (19) |
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase.
a
Reported in >20% of patients across all dose groups.
b
Laboratory evaluations.