Table 3.
JAKARTA: adverse events reported in ≥5% patients receiving fedratinib 400 mg, with a difference of >5% between the fedratinib 400 mg/day and placebo arms; and selected laboratory abnormalities that worsened from baseline (≥20% of patients), with a difference of >10% between fedratinib 400 mg/day and placebo during randomized treatment [34].
| INREBIC 400 mg (n = 96) | Placebo (n = 95) | |||
|---|---|---|---|---|
| All grades % | Grade ≥ 3a % | All grades % | Grade ≥ 3 % | |
| Adverse reactionb | ||||
| Diarrhea | 66 | 5 | 16 | 0 |
| Nausea | 62 | 0 | 15 | 0 |
| Anemia | 40 | 30 | 14 | 7 |
| Vomiting | 39 | 3.1 | 5 | 0 |
| Fatigue or asthenia | 19 | 5 | 16 | 1.1 |
| Muscle spasms | 12 | 0 | 1.1 | 0 |
| Blood creatinine increased | 10 | 1 | 1.1 | 0 |
| Pain in extremity | 10 | 0 | 4.2 | 0 |
| Alanine aminotransferase increased | 9 | 0 | 1.1 | 0 |
| Headache | 9 | 0 | 1.1 | 0 |
| Weight increased | 9 | 0 | 4.2 | 0 |
| Dizziness | 8 | 0 | 3.2 | 0 |
| Bone pain | 8 | 0 | 2.1 | 0 |
| Urinary tract infectionc | 6 | 0 | 1.1 | 0 |
| Dysuria | 6 | 0 | 0 | 0 |
| Aspartate aminotransferase increased | 5 | 0 | 1.1 | 0 |
| Selected laboratory abnormalities | ||||
| Hematology | ||||
| Anemia | 74 | 34 | 32 | 10 |
| Thrombocytopenia | 47 | 12 | 26 | 10 |
| Neutropenia | 23 | 5 | 13 | 3.3 |
| Biochemistry | ||||
| Creatinine increased | 59 | 3.1 | 19 | 1.1 |
| ALT increased | 43 | 1 | 14 | 0 |
| AST increased | 40 | 0 | 16 | 1.1 |
| Lipase increased | 35 | 10 | 7 | 2.2 |
| Hyponatremia | 26 | 5 | 11 | 4.3 |
| Amylase increased | 24 | 2.1 | 5 | 0 |
aOnly 1 Grade 4 event (anemia).
bCTCAE version 4.03.
cIncludes cystitis.