Postmarketing safety study based on Pregnancy Registry on women exposed to Palforzia during pregnancy and on infants exposed to Palforzia in utero

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  PALFORZIA
• Study drug International non-proprietary name (INN) or common name:
  DEFATTED POWDER OF ARACHIS HYPOGAEA L., SEMEN (PEANUTS)
• Anatomical Therapeutic Chemical (ATC) code:
  (V01AA08) food

  food
• Medical condition to be studied:
  Food allergy

  Anaphylactic reaction

  Term birth

  Premature delivery

  Abortion

  Stillbirth

Population studied

• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  72

Study design details

• Main study objective:
  The purpose of the pregnancy registry is to collect, analyze, and report data on pregnancy outcomes and infant outcomes after exposure to Palforzia during pregnancy.
• Outcomes:
  The following outcomes will be examined: Episodes of anaphylaxis during pregnancy, whether the patient is taking Palforzia or discontinued treatment Outcome of the pregnancy (ie, term delivery, premature delivery, type of delivery, spontaneous abortion, fetal deaths) Infant outcome at birth
• Data analysis plan:
  Data will be analyzed on an annual basis and a cumulative annual report prepared. The annual data cutoff date will be the international birthdate for Palforzia (31 Jan 2020). The report will be due within 60 days after the international birthdate. The final cumulative registry report will be due no later than 1 year after the latest estimated due date for enrolled patients in the registry. The report will contain a descriptive analysis of the safety data collected. Because retrospective reporting is subject to bias, retrospective reports will be summarized separately. Prospective reports will comprise the primary analysis cohort and are used for rate calculations. Outcomes will be reported by timing and duration of exposure to Palforzia by trimester. Attempts will be made to collect as much data as possible about reported episodes of maternal anaphylaxis.
• Summary results:
  No pregnancy exposures were reported.; Therefore, there is no data on pregnancy exposures available