A Post-marketing Safety Study to Investigate the Risk of Serious CV Events among Galcanezumab (Emgality®) Users Using the Japan Medical Data Center Claim Database (I5Q-JE-B007)

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
• Medical condition to be studied:
  Migraine

Population studied

• 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:
  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.