OBSERVED SAFETY PROFILE
MOST COMMON ADVERSE EVENTS IN >20% OF PATIENTS

ABRAXANE® for metastatic breast cancer (MBC) selected adverse reactions from phase III trial - chart

ABRAXANE® for metastatic breast cancer (MBC) selected adverse reactions from phase III trial - chart

  • a Paclitaxel injection patients received premedication.
  • b Severe events are defined as at least Grade 3 toxicity.
  • Full AR Table

    OBSERVED SAFETY PROFILE
    ADVERSE EVENTS IN A PHASE III CLINICAL TRIAL

    OBSERVED SAFETY PROFILE
    ADVERSE EVENTS IN A PHASE III CLINICAL TRIAL

    Frequencya of important treatment-emergent adverse events in the randomized study of an every-3-week schedule
     
    PERCENTAGE OF PATIENTS
     
    ABRAXANE 260 mg/m2 over 30 min (n=229)
    ABRAXANE 260 mg/m2 over 30 min (n=229)
    Paclitaxel
    injection 175 mg/m2 over 3 hb (n=225)
    Paclitaxel
    injection 175 mg/m2 over 3 hb (n=225)
     
     
     
    HEMATOLOGIC    
    BONE MARROW    
    Neutropenia    
    <2.0 x 109/L 80 82
    <0.5 x 109/L (Grade 4) 9 22
    Thrombocytopenia    
    <100 x 109/L 2 3
    <50 x 109/L (Grade ≥3) <1 <1
    Anemia    
    <11 g/dL 33 25
    <8 g/dL (Grade ≥3) 1 <1
    Infections 24 20
    Febrile Neutropenia 2 1
    Neutropenic Sepsis <1 <1
    Bleeding 2 2
    NONHEMATOLOGIC    
    HYPERSENSITIVITY REACTIONc    
    All 4 12
    Severed 0 2
    CARDIOVASCULAR    
    Vital Sign Changes During Administration    
    Bradycardia <1 <1
    Hypotension 5 5
    Severe Cardiovascular Eventsd 3 4
    ABNORMAL ECG    
    All Patients 60 52
    Patients With Normal Baseline 35 30
    RESPIRATORY    
    Cough 7 6
    Dyspnea 12 9
    SENSORY NEUROPATHY    
    Any Symptoms 71 56
    Severe Symptomsd 10 2
    MYALGIA/ARTHRALGIA    
    Any Symptoms 44 49
    Severe Symptomsd 8 4
    ASTHENIA    
    Any Symptoms 47 39
    Severe Symptomsd 8 3
    FLUID RETENTION/EDEMA    
    Any Symptoms 10 8
    Severe Symptomsd 0 <1
    GASTROINTESTINAL    
    Nausea    
    Any Symptoms 30 22
    Severe Symptomsd 3 <1
    Vomiting    
    Any Symptoms 18 10
    Severe Symptomsd 4 1
    Diarrhea    
    Any Symptoms 27 15
    Severe Symptomsd <1 1
    Mucositis    
    Any Symptoms 7 6
    Severe Symptomsd <1 0
    ALOPECIA 90 94
    HEPATIC (PATIENTS WITH NORMAL BASELINE)    
    Bilirubin Elevations 7 7
    Alkaline Phosphatase Elevations 36 31
    AST (SGOT) Elevations 39 32
    INJECTION SITE REACTION <1 1

    AST=aspartate aminotransferase; ECG=electrocardiogram; SGOT=serum glutamic-oxaloacetic transaminase.

    • aBased on worst grade by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.
    • bPaclitaxel injection patients received premedication.
    • cIncludes treatment-related events related to hypersensitivity (eg, flushing, dyspnea, chest pain, hypotension) that began on a day of dosing.
    • dSevere events are defined as at least Grade 3 toxicity.
    CLOSE THE TAB
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Additional Information for Readers Provided by Celgene Corporation

The clinical trial described in this article served as the
basis for the approval for ABRXANE for Injectable Suspension.
The analyses contained in the article may differ from those in the package insert for ABRAXANE.

Please see Important Safety Information and Prescribing Information, including Boxed WARNING.

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