Vascular Endothelial Growth Factor Inhibitors and Artery dissections and aneurysms - An analysis of EudraVigilance

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Case series review of Pharmacovigilance data
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SUNITINIB

  SORAFENIB

  PAZOPANIB

  LENVATINIB

  VANDETANIB

  AXITINIB

  PONATINIB

  REGORAFENIB

  CABOZANTINIB

  NINTEDANIB
• Medical condition to be studied:
  Aneurysm

  Artery dissection

Population studied

• Short description of the study population:
  Case reports of artery dissections and aneurysms with vascular endothelial growth factor inhibitors.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  660

Study design details

• Main study objective:
  To identify and characterise case reports of artery dissections and aneurysms with vascular endothelial growth factor inhibitors and to perform a narrative summary of the relevant individual case safety reports
• Data analysis plan:
  Descriptive statistics were performed by substance, by class, by indication, by country, by age, gender and by medical history. Boxplots of time to onset were plotted and stratified by type and number of products. Time to onset was calculated by subtracting the start date of reaction to the start date of the medicinal product. An analysis of disproportionality was conducted, stratified by indication and medical history where possible. An individual case safety review was performed. Serious case reports of aneurysm and artery dissections with negative outcomes that do not have underlying susceptibility reported, i.e. no medical history of vascular disease and/or associated risk factors, were reviewed by two independent investigators. For the purpose of selecting the case reports, different susceptibilities due to age and gender were not considered.

Documents

Study results

VEGFR and Aneurysm - EV analysis - 20190213