Table 4.

Treatment-emergent adverse reactions reported in ≥10% of patients in the clinical study

Adverse ReactionsCML-CP (n = 318)
CML-AP (n = 120)
All grades* (%)Grades 3/4 (%)All grades (%)Grades 3/4 (%)
Rash332280
Pruritus291200
Nausea31118<1
Diarrhea223192
Constipation21<1180
Vomiting21<1100
Abdominal pain111133
Headache313212
Fatigue28116<1
Pyrexia141242
Asthenia140122
Edema, peripheral110110
Arthralgia182160
Myalgia14214<1
Pain in extremity131162
Bone pain11<113<1
Muscle spasms11<1140
Back pain10<112<1
Cough17<1130
Dyspnea11183
Nasopharyngitis16<1110
  • NOTE: Treatment-emergent adverse reactions regardless of relationship to study drug and excluding laboratory abnormalities.

  • * National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.