Analysis of pregnancy pharmacovigilance data in spontaneous reports, and literature, (Individual Case Safety Reports originating from published case series, non-interventional studies and patient support programmes); demonstration study 2.5.1 of the ConcePTION project

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:
  Other
• Non-interventional study design, other:
  Descriptive study in primairy data collections

Study drug and medical condition

• Medical condition to be studied:
  Pregnancy

  Stillbirth

  Abortion spontaneous

  Ectopic pregnancy

  Congenital anomaly

  Foetal growth restriction

  Exposure during pregnancy

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To gain insight into the nature of information on drug exposure during pregnancy from spontaneous reports and literature reports
• Data analysis plan:
  data analysis plans are described under the various substudies s1-s5