A Post Marketing Safety Study of Lasmiditan (REYVOW®) to describe the use in pregnant women and pregnancy outcomes using the Japan Medical Data Center Database (H8H-MC-B011)

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:
  (N02CC08) lasmiditan

  lasmiditan
• 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)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To describe lasmiditan use during pregnancy and to estimate the prevalence of pregnancy adverse events (spontaneous abortions, stillbirths, major congenital malformations, low birth weight, and preterm births) in pregnant women with migraine who are exposed to lasmiditan.
• Outcomes:
  pregnancy adverse events (spontaneous abortions, stillbirths, major congenital malformations, low birth weight, and preterm births)
• Data analysis plan:
  Descriptive statistics will be used to describe variables listed in the study protocol. For continuous variables, mean and SD, and median and IQR will be presented. For categorical and binary variables, frequency and percentage will be calculated.