Bone pain 12 <1 12 1 11 3 9 3
General disorders and administration site conditions
Fatigue or asthenia 39 3 36 6 35 5 31 3
Pyrexia 23 1 31 5 32 3 25 0
Edema, peripheral 13 <1 19 0 13 0 22 0
Pain 8 <1 7 0 16 3 6 3
Chills 7 0 11 0 13 2 9 0
Metabolism and nutrition disorders
Decreased appetite 8 <1 12 1 8 0 31 0
Investigations
Weight decreased 6 <1 7 0 5 0 13 0
Psychiatric disorders
Insomnia 7 0 12 0 8 0 9 0
Table 5: Serious Adverse Reactions (SAR) N (%)
*
includes pericardial effusion, pleural effusion, and ascites
Cardiovascular disorders
Arterial ischemic event 34 (8%)
Myocardial infarction or worsening coronary artery disease 21 (5%)
Stroke or TIA 8 (2%)
Peripheral arterial disease 7 (2%)
Hemorrhage 22 (4%)
CNS hemorrhage 10 (2%)
Gastrointestinal hemorrhage 10 (2%)
Cardiac failure 20 (4%)
Effusions* 13 (3%)
Atrial fibrillation 11 (2%)
Venous thromboembolism 10 (2%)
Hypertension 8 (2%)
Gastrointestinal disorders
Pancreatitis 23 (5%)
Abdominal pain 17 (4%)
Blood and lymphatic system disorders
Febrile neutropenia 13 (3%)
Thrombocytopenia 13 (3%)
Anemia 12 (2%)
Infections
Pneumonia 24 (4%)
Sepsis 11 (2%)
General
Pyrexia 14 (3%)
Laboratory Abnormalities
Myelosuppression was commonly reported in all patient populations. The frequency of Grade 3 or 4 thrombocytopenia, neutropenia, and anemia was higher in patients with AP-CML, BP-CML, and Ph+ALL than in patients with CP-CML (see Table 6).
Table 6: Incidence of Clinically Relevant Grade 3/4* Hematologic Abnormalities Laboratory Test CP-CML
(N=270)
(%) AP-CML
(N=85)
(%) BP-CML
(N=62)
(%) Ph+ ALL
(N=32)
(%)
ANC=absolute neutrophil count, Hgb=hemoglobin, WBC=white blood cell count
*
Reported using NCI-CTC-AE v 4.0
Hematology
Thrombocytopenia (platelet count decreased) 36 47 57 47
Neutropenia (ANC decreased) 24 51 55 63
Leukopenia (WBC decreased) 14 35 53 63
Anemia (Hgb decreased) 9 26 55 34
Lymphopenia 10 26 37 22
ANC=absolute neutrophil count, Hgb=hemoglobin, WBC=white blood cell count
*
Reported using NCI-CTC-AE v 4.0
Table 7 Incidence of Clinically Relevant Non-Hematologic Laboratory Abnormalities Laboratory Test Safety Population
N=449
Any Grade*
(%) G3-4
(%)
Liver function tests
ALT increased 53 8
AST increased 41 4
Alkaline phosphatase increased 37 2
Albumin decreased 28 1
Bilirubin increased 19 1
Pancreatic enzymes
Lipase increased 41 15
Amylase increased 3 <1
Chemistry
Glucose increased 58 6
Phosphorus decreased 57 8
Calcium decreased 52 1
Sodium decreased 29 5
Glucose decreased 24 0
Potassium decreased 16 2
Potassium increased 15 2
