Clinical Data

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Rate of Adverse Events

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Neutrophil and Platelet Recovery

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Mortality Rates

The overall frequency and severity of adverse events was comparable for VYXEOS and 7+31,2

  • In the phase 3 study, Vyxeos increased overall survival without increasing toxicity burden2
  • VYXEOS was associated with an increased risk of neutropaenia and thrombocytopaenia so patients may additional monitoring.2 Refer to the summary of product characteristics for full details.
  • Median time to recovery from thrombocytopaenia (≥ 50,000/µl) after first induction for patients who had received CR/CRi was 36.5 days vs 29 days for VYXEOS and 7+3 chemotherapy, respectively2
  • Median time to recovery from neutropaenia (ANC value ≥ 500/µl) after first induction for patients who had achieved CR/CRi was 35 days vs 29 days for VYXEOS and 7+3 chemotherapy, respectively2
  • Lower early mortality rates were reported with Vyxeos than 7+3 chemotherapy2

References

  1. Vyxeos summary of product characteristics
  2. Lancet JE et al. 2018. J Clin Oncol 2018. Published online ahead of print. doi: 10.1200/JCO.2017.77.6112
  3. Jazz Pharmaceuticals. Data on File.

 

 

ADVERSE EVENTS REPORTING

 

Reporting of side effects: Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via their national reporting system. In the United Kingdom, reporting forms and information can be found at https://yellowcard.mhra.gov.uk/. Adverse events should also be reported by email: AEreporting@jazzpharma.com or by fax to +44 (0) 1865 598765

 

EURW-INTVYX-0020a(1) | September 2019