13) 3 (1) 19 (14) 0 72 (13) 3 (1)
Musculoskeletal and Connective Tissue Disorder
Arthalgia 58 (14) 2 (<1) 18 (13) 0 76 (14) 2 (<1)
Back pain 49 (12) 3 (1) 10 (7) 2 (1) 59 (11) 5 (1)
Nervous System Disorders
Headache 82 (20) 3 (1) 25 (18) 6 (4) 107 (20) 9 (2)
Dizziness 39 (10) 0 18 (13) 1 (1) 57 (10) 1 (<1)
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 41 (10) 4 (1) 26 (19) 8 (6) 67 (12) 12 (2)
Cough 80(20) 0 30(21) 0 110(20) 0
Skin and Subcutaneous Disorders
Rash¶ 140 (34) 32 (8) 49 (35) 6 (4) 189 (35) 38 (7)
Pruritus 43 (11) 3 (1) 11 (8) 0 54 (10) 3 (1)
Abdominal pain includes the following preferred terms: Abdominal pain, Abdominal pain upper, Abdominal pain lower, Abdominal tenderness, Gastrointestinal pain, Abdominal discomfort
†
Fatigue includes the following preferred terms: Fatigue, Malaise
‡
Edema includes the following preferred terms: Edema, Edema peripheral, Localized edema, Face edema
§
Respiratory tract infection includes the following preferred terms: Respiratory tract infection, Upper respiratory tract infection, Lower respiratory tract infection, Viral upper respiratory tract infection, Respiratory tract infection viral
¶
Rash includes the following preferred terms: Rash, Rash macular, Rash pruritic, Rash generalized, Rash papular, Rash maculo-papular
In the single-arm Phase 1/2 clinical trial, one patient (0.2%) experienced QTcF interval of greater than 500 ms. Patients with uncontrolled or significant cardiovascular disease including QT interval prolongation were excluded by protocol.
Table 3 identifies the clinically relevant or severe Grade 3/4 laboratory test abnormalities for the Phase 1/2 CML safety population.
Table 3: Number (%) of Patients with Clinically Relevant or Severe Grade 3/4 Laboratory Test Abnormalities In the Phase 1/2 Clinical Study, Safety Population CP CML
N=406
n (%) AdvP CML
N=140
n (%) All CP and AdvP CML
N=546
n (%)
Hematology Parameters
Platelet Count (Low) less than 50 × 109/L 102 (25) 80 (57) 182 (33)
Absolute Neutrophil Count less than 1 × 109/L 74 (18) 52 (37) 126 (23)
Hemoglobin (Low) less than 80 g/L 53 (13) 49 (35) 102 (19)
Biochemistry Parameters
SGPT/ALT greater than 5.0 × ULN 39 (10) 8 (6) 47 (9)
SGOT/AST greater than 5.0 × ULN 17 (4) 4 (3) 21 (4)
Lipase greater than 2 × ULN 33 (8) 4 (3) 37 (7)
Phosphorus (Low) less than 0.6 mmol/L 30 (7) 10 (7) 40 (7)
Total Bilirubin greater than 3.0 × ULN 3 (1) 2 (1) 5 (1)
Additional Data from Multiple Clinical Trials
The following adverse reactions were reported in patients in clinical trials with Bosulif (less than 10% of Bosulif-treated patients). They represent an eva luation of the adverse reaction data from 870 patients with Ph+ leukemia who received at least 1 dose of single-agent Bosulif. These adverse reactions are presented by system organ class and are ranked by frequency. These adverse reactions are included based on clinical relevance and ranked in order of decreasing seriousness within each category.
Blood and Lymphatic System Disorders: 1% and less than 10% - febrile neutropenia
Cardiac Disorders: 1 |
