Serious adverse reactions occurred in 23% of patients who received SCEMBLIX. Serious adverse reactions in >1% included abdominal pain (4.2%), vomiting (4.2%), pneumonia (4.2%), musculoskeletal pain (2.1%), headache (2.1%), hemorrhage (2.1%), constipation (2.1%), arrhythmia (2.1%), and pleural effusion (2.1%).1
aURTI includes: nasopharyngitis, upper respiratory tract infection, rhinitis, pharyngitis, respiratory tract infection, and pharyngotonsillitis.
bMusculoskeletal pain includes: pain in extremity, back pain, myalgia, non-cardiac chest pain, neck pain, bone pain, spinal pain, arthritis, musculoskeletal pain, and musculoskeletal chest pain.
cHeadache includes: headache and post-traumatic headache.
dFatigue includes: fatigue and asthenia.
eRash includes: rash, rash maculopapular, dermatitis acneiform, rash pustular, eczema, dermatitis, skin exfoliation, dermatitis exfoliative generalized, rash morbilliform, drug eruption, erythema multiform, and rash erythematous.
fHypertension includes: hypertension and hypertensive crisis.
gAbdominal pain includes: abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, abdominal tenderness, and epigastric discomfort.
hDiarrhea includes: diarrhea and colitis.
iThe denominator used to calculate the rate for SCEMBLIX and bosutinib varied from 145 to 156 and 71 to 76, respectively, based on the number of patients with a baseline value and at least one post-treatment value.
jMusculoskeletal pain includes: pain in extremity, back pain, myalgia, musculoskeletal pain, non-cardiac chest pain, bone pain, arthritis, and musculoskeletal chest pain.
kRash includes: rash, rash maculopapular, dermatitis acneiform, eczema, rash papular, skin exfoliation, and dyshidrotic eczema.
lHeadache includes: headache and migraine.
mAbdominal pain includes: abdominal pain and hepatic pain.
nHemorrhage includes: epistaxis, ear hemorrhage, mouth hemorrhage, postprocedural hemorrhage, skin hemorrhage, and vaginal hemorrhage.
oCough includes: cough and productive cough.
pURTI includes: upper respiratory tract infection, nasopharyngitis, rhinitis, and pharyngitis.
qThe denominator used to calculate the rate was 48 based on the number of patients with a baseline value and at least one post-treatment value.
References: 1. Data on file. CABL001A2301 clinical study report. Novartis Pharmaceuticals Corp; 2022. 2. Scemblix [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 3. Data on file. CABL001A Week 96 SCS. Novartis Pharmaceuticals Corp; 2022.
View the SCEMBLIX patient profiles >