ology 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)
6.2 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% and less than 10% - pericardial effusion; 0.1% and less than 1% - pericarditis
Ear and Labyrinth Disorders: 1% and less than 10% - tinnitus
Gastrointestinal Disorders: 1% and less than 10% - gastritis; 0.1% and less than 1% - acute pancreatitis, gastrointestinal hemorrhage1
General Disorders and Administrative Site Conditions: 1% and less than 10% - chest pain2, pain
Hepatobiliary Disorders: 1% and less than 10% - hepatotoxicity3, abnormal hepatic function4; 0.1% and less than 1% - liver injury
Immune System Disorders: 1% and less than 10% - drug hypersensitivity; 0.1% and less than 1% - anaphylactic shock
Infections and Infestations: 1% and less than 10% - pneumonia5, influenza, bronchitis
Investigations: 1% and less than 10% - electrocardiogram QT prolonged, increased blood creatine phosphokinase, increased blood creatinine
Metabolism and Nutrition Disorder: 1% and less than 10% - hyperkalemia, dehydration
Musculoskeletal and Connective Tissue Disorder: 1% and less than 10% - myalgia
Nervous System Disorders: 1% and less than 10% - dysgeusia
Renal and Urinary Disorders: 1% and less than 10% - acute renal failure, renal failure
Respiratory, Thoracic and Mediastinal Disorders: 1% and less than 10% - pleural effusion; 0.1% and less than 1% - acute pulmonary edema, respiratory failure, pulmonary hypertension
Skin and Subcutaneous Disorders: 1% and less than 10% - urticaria, pruritus, acne; 0.1% and less than 1% - erythema multiforme, exfoliative rash, drug eruption
1
Gastrointestinal hemorrhage includes the following preferred terms: gastrointestinal hemorrhage, gastric hemorrhage, upper gastrointestinal hemorrhage
2
Chest pain includes the following preferred terms: chest pain, chest discomfort
3
Hepatotoxicity includes the following preferred terms: hepatoxicity, toxic hepatitis, cytolytic hepatitis
4
Abnormal hepatic function includes the following preferred terms: abnormal hepatic function, liver disorder
5
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