Table 6.
Dasatinib2 100 mg QDa (n = 258) |
Imatinib1 400 mg QDb (n = 551) |
Nilotinib3 300 mg BIDc (n = 279) |
||||
---|---|---|---|---|---|---|
All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | |
Nonhematologic AE | ||||||
Abdominal pain | 11 | 0 | 37 | 4 | 15 | 2 |
Constipation | NR | NR | 11 | 1 | 20 | <1 |
Cough | NR | NR | 20 | <1 | 17 | 0 |
Diarrhea | 22 | 1 | 45 | 3 | 19 | 1 |
Dizziness | NR | NR | 19 | 1 | 12 | <1 |
Dyspepsia | NR | NR | 19 | 0 | 10 | 0 |
Fatigue | 11 | <1 | 39 | 2 | 23 | 1 |
Fluid retention | 38 | 5 | 62 | 3 | NR | 4 |
Headache | 14 | 0 | 37 | 1 | 32 | 3 |
Influenza | NR | NR | 14 | <1 | 13 | 0 |
Insomnia | NR | NR | 15 | 0 | 11 | 0 |
Arthralgia/joint pain | 7 | 0 | 31 | 3 | 22 | <1 |
Myalgia | 7 | 0 | 24 | 2 | 19 | <1 |
Nasopharyngitis | NR | NR | 31 | 0 | 27 | 0 |
Nausea | 10 | 0 | 50 | 1 | 22 | 2 |
Pyrexia | NR | NR | 18 | 1 | 14 | <1 |
Rash and related termsd | 14 | 0 | 40 | 3 | 38 | <1 |
Upper respiratory tract infection | NR | NR | 21 | <1 | 17 | <1 |
Vomiting | 5 | 0 | 23 | 2 | 15 | <1 |
Hematologic AE | ||||||
Neutropenia | 29 | 17 | 12 | |||
Thrombocytopenia | 22 | 9 | 10 | |||
Anemia | 13 | 4 | 4 |
AE: adverse event; BID: twice daily; NR: not reported in ≥10% of patients; QD: once daily; TKI: tyrosine kinase inhibitor.
Minimum of 60 months follow-up.2
Study versus interferon-α.1
60-month analysis.3
Includes erythema, erythema multiforme, rash, rash generalized, rash macular, rash papular, rash pustular, skin exfoliation, and rash vesicular.