WELL-ESTABLISHED SAFETY PROFILE

Selected ARs with a difference of ≥5% for all grades or ≥2% for Grades 3-4 toxicity between treatment groups
Selected adverse reactions in the ABRAXANE (100 mg/m2 weekly) + carboplatin arm (n=514) vs the paclitaxel injection (200 mg/m2 Q3W) + carboplatin arm (n=524): anemia (98% vs 91%, all grades; 28% vs 7%, Grades 3-4), neutropenia (85% vs 83%, all grades; 47% vs 58%, Grades 3-4), thrombocytopenia (68% vs 55%, all grades; 18% vs 9%, Grades 3-4), peripheral neuropathy (48% vs 64%, all grades; 3% vs 12%, Grades 3-4), edema peripheral (10% vs 4%, all grades; 0% vs <1%, Grades 3-4), epistaxis (7% vs 2%, all grades; 0% vs 0%, Grades 3-4), arthralgia (13% vs 25%, all grades; <1% vs 2%, Grades 3-4), and myalgia (10% vs 19%, all grades; <1% vs 2%, Grades 3-4) - table Selected adverse reactions in the ABRAXANE (100 mg/m2 weekly) + carboplatin arm (n=514) vs the paclitaxel injection (200 mg/m2 Q3W) + carboplatin arm (n=524): anemia (98% vs 91%, all grades; 28% vs 7%, Grades 3-4), neutropenia (85% vs 83%, all grades; 47% vs 58%, Grades 3-4), thrombocytopenia (68% vs 55%, all grades; 18% vs 9%, Grades 3-4), peripheral neuropathy (48% vs 64%, all grades; 3% vs 12%, Grades 3-4), edema peripheral (10% vs 4%, all grades; 0% vs <1%, Grades 3-4), epistaxis (7% vs 2%, all grades; 0% vs 0%, Grades 3-4), arthralgia (13% vs 25%, all grades; <1% vs 2%, Grades 3-4), and myalgia (10% vs 19%, all grades; <1% vs 2%, Grades 3-4) - table
  • a508 patients assessed in ABRAXANE + carboplatin–treated group.
  • b514 patients assessed in paclitaxel injection + carboplatin–treated group.
  • c513 patients assessed in paclitaxel injection + carboplatin–treated group.
  • dPeripheral neuropathy is defined by the MedDRA v14.0 SMQ neuropathy (broad scope).
  • AR=adverse reaction; MedDRA=Medical Dictionary for Regulatory Activities; Q3W=every 3 weeks; SMQ=Standardized MedDRA Query.
  • a508 patients assessed in ABRAXANE + carboplatin–treated group.
  • b514 patients assessed in paclitaxel injection + carboplatin–treated group.
  • c513 patients assessed in paclitaxel injection + carboplatin–treated group.
  • dPeripheral neuropathy is defined by the MedDRA v14.0 SMQ neuropathy (broad scope).
  • AR=adverse reaction; MedDRA=Medical Dictionary for Regulatory Activities; Q3W=every 3 weeks; SMQ=Standardized MedDRA Query.
  • Most Common Adverse Reactions

    ESTABLISHED SAFETY PROFILE IN ADVANCED NSCLC

    Common ARs (≥10%) for ABRAXANE + carboplatin observed at a similar incidence as with paclitaxel injection + carboplatin
    Common ARs (≥10%) for ABRAXANE + carboplatin observed at a similar incidence as with paclitaxel injection + carboplatin
    Common adverse reactions in the ABRAXANE (100 mg/m2 weekly) + carboplatin arm (n=514): alopecia (56%), nausea (27%), fatigue (25%), decreased appetite (17%), asthenia (16%), constipation (16%), diarrhea (15%), vomiting (12%), dyspnea (12%), and rash (10%) - table Common adverse reactions in the ABRAXANE (100 mg/m2 weekly) + carboplatin arm (n=514): alopecia (56%), nausea (27%), fatigue (25%), decreased appetite (17%), asthenia (16%), constipation (16%), diarrhea (15%), vomiting (12%), dyspnea (12%), and rash (10%) - table
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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 ABRAXANE 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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