A Retrospective Cohort Study for Estimating Incidence Rates of Infusion Site Events for ABBV-951 for the Treatment of Advanced Parkinson's Disease

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Foslevodopa/Foscarbidopa
• Medical condition to be studied:
  Parkinson's disease

Population studied

• Special population of interest:
  Immunocompromised

  Other
• Special population of interest, other:
  Diabetes Mellitus

Study design details

• Study design:
  A longitudinal, retrospective cohort study of individuals with advanced PD treated with ABBV-951 in Finland and France. The overall study period will be from the date of market availability (anticipated Q4 2023) until Q1 2027. Index date will be defined as the date of first initiation of ABBV-951.
• Main study objective:
  • To quantify the incidence rate of first infusion site event (first infusion site infection OR first serious infusion site reaction); • To quantify the incidence rate of first infusion site infection; • To quantify the incidence rate of first serious infusion site reaction
• Outcomes:
  • Infusion site event (first occurrence only) defined as infusion site infection OR serious infusion site reaction; • Infusion site infection (first occurrence only); • Serious infusion site reactions (first occurrence only);