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

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)

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.