Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N02CD02) galcanezumab
galcanezumab

Medical condition to be studied

Migraine
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

6599
Study design details

Main study objective

The primary objective of this study is to describe the incidence rate of serious CV events among migraine patients treated with galcanezumab. This objective is descriptive and aims to describe the incidence and distribution of time to first serious CV events in adult patients treated with galcanezumab, overall, by age, gender, and treatment duration of galcanezumab.

Outcomes

Serious CV events

Data analysis plan

Calculate the descriptive statistics of the patient characteristics at baseline among galcanezumab group. The incidence and distribution of time to serious CV events among migraine patients treated with galcanezumab, overall, by age, and gender will be described. Incidence of serious CV events of the special populations of interest including with CV events during 12 months prior to initiation of galcanezumab will be calculated. Subgroup analysis for duration of the galcanetumab treatment (e.g. ?18 mo) will be conducted to investigate incidence of serious CV events of galcanetumab users with long-term exposure. Time-to-event analysis using the Kaplan-Meier method will be performed. The patient will be either to have a event or censored at the end of follow-up period.