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

Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Adults (18 to < 46 years)

Special population of interest

Pregnant women

Estimated number of subjects

1000
Study design details

Main study objective

to assess major congenital malformations, spontaneous abortions, stillbirths, preeclampsia, eclampsia, preterm delivery, low birth weight, and small-for-gestational age births in women exposed to AJOVY during pregnancy compared to comparison groups unexposed to AJOVY.

Outcomes

major congenital anomalies, spontaneous abortions, stillbirths, preeclampsia, eclampsia, preterm delivery, low birth weight, and small-for-gestational age births.

Data analysis plan

Study data will be summarized using descriptive statistics. The prevalence of major congenital malformations and secondary endpoints will be calculated as the proportion of events identified in the database of all live births or of pregnancies, as applicable. Analyses of the primary and secondary endpoints between the AJOVY group and Comparison Groups I and II are the primary comparisons of interest. Analyses using Comparison Groups III and IV are considered supportive. Analyses will be performed to compare the rates of major congenital malformations between the AJOVY group and each of Comparison Groups I and II, using a generalized linear model, adjusting for mother’s age as a continuous covariate, and stratified by gestational timing of exposure.