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

Name of medicine

AJOVY

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

6000
Study design details

Main study objective

To evaluate the long-term safety of fremanezumab in all patients with migraine and to evaluate the safety of fremanezumab in cardiovascular compromised patients with migraine with regard to cardiovascular events.

Outcomes

All adverse events

Data analysis plan

The primary analysis will focus on the comparison of the incidence of all adverse events in patients currently exposed to fremanezumab (Cohort 1), non fremanezumab CGRP-pathway targeting preventive migraine medications (Cohort 2), or non CGRP-pathway targeting preventive migraine medications (Cohort 3). Summary statistics for the incidence of adverse events in patients with migraine, the sub-population of CV compromised patients with major CV disease or hypertension, and the incidence of adverse events by treatment duration will be reported for each cohort. In addition, summary statistics will be provided by migraine treatment duration, and for CV compromised patients by their CV disease/hypertension status (current or history), for each cohort. Rates for adverse events per person-year of observation will be calculated by cohort. Unadjusted difference of incidence rates with 95% CIs of all adverse events between the treatment cohorts will also be calculated.