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. Author manuscript; available in PMC: 2019 Aug 6.
Published in final edited form as: Expert Opin Orphan Drugs. 2015 Apr 16;3(5):599–608. doi: 10.1517/21678707.2015.1036027

Table 2:

Adverse events (≥10%) following bosutinib in Advanced Phase* CML32 (Reproduced with permission)

Adverse event (non-hematologic) Advanced Phase* CML N (%)
Diarrhea
 All grade 122 (74)
 Grade 3/4 8 (5)
Nausea
 All grade 80 (48)
 Grade 3/4 3 (2)
Vomiting
 All grade 72 (43)
 Grade 3/4 6 (4)
Rash
 All grade 51 (31)
 Grade 3/4 6 (4)
Pyrexia
 All grade 64 (39)
 Grade ¾ 5 (3)
Fatigue
 All grade 35 (21)
 Grade   7 (4)
Abdominalpain
 All grade 35 (21)
 Grade ¾ 4 (2)
Headache
 All grade 31 (19)
 Grade 3/4 7 (4)
Cough
 All grade 34 (21)
 Grade 3/4 0
Elevated ALT
 All grade 17 (10)
 Grade 3/4 7 (4)
Upper abdominal pain 17 (10
 All grade 3 (2)
 Grade 3/4
Elevated AST
 All grade 17 (10)
 Grade 3/4 5 (3)
Arthralgia
 All grade 22 (13)
 Grade 3/4 1 (1)
Decreased appetite
 All grade 21 (13)
 Grade 3/4 0
Constipation
 All grade 27 (16)
 Grade 3/4 1 (1)
Dyspnea
 All grade 32 (19)
 Grade 3/4 9 (5)
Asthenia 20 (12)
 All grade 1(1)
 Grade 3/4
Dizziness
 All grade 21 (13)
 Grade 3/4 1 (1)
Peripheral edema
 All grade 17 (10)
 Grade 3/4 1 (1)
Extremity pain
 All grade 18(11)
 Grade 3/4 1 (1)
Pleural effusion
 All grade 16 (10)
 Grade 3/4 7 (4)

Adverse event (hematologic)

Thrombocytopenia
 All grade 74 (45)
 Grade 3/4 65 (39)
Anemia
 All grade 64 (39)
 Grade 3/4 42 (25)
Neutropenia
 All grade 36 (22)
 Grade 3/4 33 (20)

Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CML, chronic myeloid leukemia

*

Advanced phase CML included patients in accelerated phase, blast phase and patients with acute lymphoblastic leukemia