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ADVERSE EVENTS

  • From the pembrolizumab Prescribing Information
    Safety data are available for the first 203 patients who received pembrolizumab and chemotherapy (n=101) or placebo and chemotherapy (n=102)12
    • Pembrolizumab was discontinued for adverse reactions in 15% of patients, with no single type of adverse reaction accounting for the majority
    • Adverse reactions leading to interruption of pembrolizumab occurred in 43% of patients. Most common (≥2%) were:
      Thrombocytopenia (20%)
      Asthenia (2%)
      Neutropenia (11%)
      Diarrhea (2%)
      Anemia (6%)
    • The most frequent (≥2%) serious adverse reactions were febrile neutropenia (6%), pneumonia (6%), and urinary tract infection (3%)
    • Increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the pembrolizumab and chemotherapy arm compared to the placebo and chemotherapy arm
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  • From the New England Journal of Medicine

    Data cutoff April 3, 2018

    Adverse events of any cause occurring in ≥15% of patients in either group11*

    Safety data are available for the as-treated population who received pembrolizumab and chemotherapy (n=278) or placebo and chemotherapy (n=280).11

    Adverse reactions in the pembrolizumab combination arm (n=278) vs the placebo combination arm (n=280): anemia (148 [53.2%] vs 145 [51.8%], any grade; 43 [15.5%] vs 57 [20.4%], Grade 3, 4, or 5), alopecia (128 [46.0%] vs 102 [36.4%], any grade; 1 [0.4%] vs 3 [1.1%], Grade 3, 4, or 5), neutropenia (105 [37.8%] vs 92 [32.9%], any grade; 63 [22.7%] vs 69 [24.6%], Grade 3, 4, or 5), nausea (99 [35.6%] vs 90 [32.1%], any grade; 3 [1.1%] vs 4 [1.4%], Grade 3, 4, or 5), thrombocytopenia (85 [30.6%] vs 65 [23.2%], any grade; 19 [6.8%] vs 18 [6.4%], Grade 3, 4, or 5), diarrhea (83 [29.9%] vs 65 [23.2%], any grade; 11 [4.0%] vs 6 [2.1%], Grade 3, 4, or 5),
decreased appetite (68 [24.5%] vs 82 [29.3%], any grade; 6 [2.2%] vs 5 [1.8%], Grade 3, 4, or 5), constipation (64 [23.0%] vs 61 [21.8%], any grade; 2 [0.7%] vs 3 [1.1%], Grade 3, 4, or 5), fatigue (63 [22.7%] vs 72 [25.7%], any grade; 9 [3.2%] vs 11 [3.9%], Grade 3, 4, or 5), asthenia (60 [21.6%] vs
59 [21.1%], any grade; 6 [2.2%] vs 10 [3.6%], Grade 3, 4, or 5), arthralgia (57 [20.5%] vs 40 [14.3%], any grade; 4 [1.4%] vs 2 [0.7%], Grade 3, 4, or 5), peripheral neuropathy (57 [20.5%] vs 45 [16.1%], any grade; 3 [1.1%] vs 2 [0.7%], Grade 3, 4, or 5), vomiting (45 [16.2%] vs 33 [11.8%], any grade; 1
[0.4%] vs 6 [2.1%], Grade 3, 4, or 5), cough [37 [13.3%] vs 47 [16.8%], any grade; 2 [0.7%] vs 3 [1.1%], Grade 3, 4, or 5), and dyspnea (36 [12.9%] vs 45 [16.1%], any grade; 4 [1.4%] vs 3 [1.1%], Grade 3, 4, or 5). None of these events were of Grade 5 severity.

    *Includes adverse events that occurred during randomly allocated study treatment or within the 30 days thereafter (within 90 days for serious events), regardless of attribution to study treatment by the investigator. Adverse events that occurred during in-study crossover are excluded. The as-treated population included all patients who underwent randomization and received ≥1 dose of study treatment.11


    In the pembrolizumab Prescribing Information these data were different: adverse events for alopecia 47% vs 36% and peripheral neuropathy 31% vs 25% were observed in the pembrolizumab and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.12


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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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