Assessment of pregnancy outcomes in patients treated with reslizumab: Active pregnancy surveillance

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

• Medicinal product name, other:
  Cinqair
• Medical condition to be studied:
  Asthma

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  266

Study design details

• Main study objective:
  To examine pregnant women exposed to reslizumab during pregnancy and to evaluate pregnancy outcomes of major birth defects
• Outcomes:
  The primary outcome is major birth defects in prospective cases of females exposed to reslizumab during pregnancy. The secondary outcomes are pre-term birth, stillbirth, and spontaneous abortion.
• Data analysis plan:
  The proportion of major birth defects of prospective cases and 95% confidence interval (CI0 will be calculated. Prevalence rates of all secondary endpoints with 95% CIs around the estimated rates will be calculated for pre-term birth, spontaneous abortions, and stillbirth.