SAFETY
Patient portrayal
AYVAKIT was generally well tolerated in PIONEER1
ADVERSE REACTIONS OCCURRING IN PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM) DURING PIONEER TRIAL1
Adverse Reactiona,b | AYVAKIT (25 mg once daily) + BSC n=141, % | Placebo + BSC n=71, % |
---|---|---|
Eye edemac | 13 | 7 |
Dizzinessd | 13 | 10 |
Peripheral edemad | 12 | 6 |
Flushingd | 11 | 4 |
Respiratory tract infectione | 8 | 1 |
Face edema | 7 | 1 |
Rashd | 6 | 4 |
Liver transaminase increasedd | 6 | 3 |
Insomnia | 6 | 3 |
Hematomaf | 6 | 1 |
Blood alkaline phosphatase increased | 6 | 1 |
Hemorrhageg | 5 | 3 |
aAdverse reactions that occurred in ≥5% of AYVAKIT-treated patients and ≥2% more than placebo-treated patients.
bPer National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
cEye edema includes periorbital edema, eye edema, swelling of eyelid, orbital edema, eye swelling, eyelid edema and eyelid ptosis.
dTerm includes several similar terms.
eRespiratory tract infection includes pneumonia, upper respiratory tract infection, bronchitis and respiratory tract infection.
fHematoma includes contusion, hematoma and pelvic hematoma.
gHemorrhage includes epistaxis, gingival bleeding, hematochezia, rectal hemorrhage, retinal hemorrhage.
- Serious adverse reactions occurred in 1 patient (0.7%) who received AYVAKIT due to pelvic hematoma1
- Permanent discontinuation of AYVAKIT due to an adverse reaction occurred in 1 patient (0.7%) due to dyspnea and dizziness1
- Dosage interruptions of AYVAKIT due to an adverse reaction occurred in 5% of patients1
- Of all adverse reactions, 55% were Grade 1, 38% were Grade 2, and 7% were Grade 31
- Among patients with edema adverse reactions, 95% were Grade 1 and 5% were Grade 2. Among patients with hemorrhage adverse reactions, 86% were Grade 1 and 14% were Grade 21
BSC=best supportive care.