Table 6

Treatment-emergent adverse events and laboratory abnormalities

EventImatinib resistant (n = 200)Imatinib intolerant (n = 88)Total (N = 288)
AllGr 3/4AllGr 3/4AllGr 3/4
No.%No.%No.%No.%No.%No.%
Nonhematologic TEAEs occurring with any grade in 10% or more of patients
    Diarrhea169851587484111324384269
    Nausea8442004450451284441
    Rash*8543179414791012644269
    Vomiting6734323439671013593
    Abdominal pain442221212411652331
    Upper abdominal pain381900161800541900
    Fatigue422100222522642221
    Pyrexia48241112140060211< 1
    Cough341700121400461600
    Headache291500171900461600
    Edema28141114160042151< 1
    Arthralgia26130013151139141< 1
    Decreased appetite251321121400371321
    Constipation1790015171132111< 1
    Back pain12600161800281000
    Nasopharyngitis191000101100291000
Hematologic laboratory abnormalities (all grades)
    Anemia18291201076861618258903613
    Thrombocytopenia§13166392060682933191666824
    Neutropenia7437281442482528116405318
Other laboratory abnormalities occurring with grade 3/4 severity in 4% or more of patients
    Elevated ALT11156201058661011169593010
    Elevated AST95488446526714149145
    Hypophosphatemia884418936416712443248
    Elevated uric acid894512631355612042176
    Hypocalcemia75385340455611540103
    Elevated lipase50251892933677927248
    Hypermagnesemia47241682630182073253412
    Elevated INR522632192245712572
    Hypomagnesemia442211121400561910
  • ALT indicates alanine aminotransferase; AST, aspartate aminotransferase; Gr, grade; INR, international normalized ratio; and TEAE, treatment-emergent adverse event.

  • * Rash includes acne, allergic dermatitis, erythema, exfoliative rash, folliculitis, heat rash, rash, rash erythematous, rash macular, rash papular, rash pruritic, and skin exfoliation.

  • Edema includes edema, face edema, localized edema, edema peripheral, periorbital edema, and pitting edema.

  • At baseline, anemia was reported by 125 (63%) imatinib-resistant patients and 45 (51%) imatinib-intolerant patients.

  • § At baseline, thrombocytopenia was reported by 34 (17%) imatinib-resistant patients and 19 (22%) imatinib-intolerant patients.

  • At baseline, neutropenia was reported by 18 (9%) imatinib-resistant patients and 13 (15%) imatinib-intolerant patients.