A Retrospective Cohort Study to Assess Drug Utilisation and Long-Term Safety of Galcanezumab in European Patients in the Course of Routine Clinical Care (I5Q-MC-B002)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  GALCANEZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (N02CD02) galcanezumab

  galcanezumab
• Medical condition to be studied:
  Migraine

  Cluster headache
• Additional medical condition(s):
  serious cardiovascular events, malignancy, and serious hypersensitivity events

Population studied

• Short description of the study population:
  The source population will include all patients with a prescription or dispensing ; of galcanezumab in the population-based healthcare databases from seven different ; European countries including France (FR), Germany (DE), Italy (IT), the Netherlands (NL), Spain ; (ES), Sweden (SE) and the United Kingdom (UK).
• Age groups:
  • 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:
  100

Study design details

• Study design:
  An observational, prevalent new-user cohort study using data from various population-based healthcare databases from seven different European countries.
• Main study objective:
  To evaluate the utilisation and long-term safety of galcanezumab in Europe, in routine clinical practice.
• Setting:
  Seven different European countries including France (FR), Germany (DE), Italy (IT), the Netherlands (NL), Spain ; (ES), Sweden (SE) and the United Kingdom (UK).
• Comparators:
  If feasible, based on accrual of target sample size, comparative analyses will be conducted to compare the incidence of serious CV and malignancy events among migraine patients that are new users of galcanezumab with propensity score-matched users of topiramate.
• Outcomes:
  Cardiovascular, malignancy, and serious hypersensitivity.
• Data analysis plan:
  Descriptive analysis