A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy® with 5-year Pediatric Follow-up (CA184-487)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Safety surveilance study

Study drug and medical condition

• Name of medicine:
  YERVOY
• Medical condition to be studied:
  Malignant melanoma

Population studied

• Short description of the study population:
  Pregnant women exposed to ipilimumab.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  10

Study design details

• Main study objective:
  The research question to be addressed by this safety surveillance study is: what are the pregnancy outcomes and offspring outcomes through 5 years of life following maternal exposure to ipilimumab during pregnancy or 90 days within treatment discontinuation?Study population: 1) pregnant women, 2) new-born, infants and children (male and female) up to 5 years of age.
• Outcomes:
  Pregnancy: Pregnancies resulting in spontaneous or elective abortion, fetal death, preterm birth, ectopic or molar pregnancyFetal and pediatric: Small-for gestational age, birth defects, congenital anomalies, delays in growth and development milestones, clinical signs of immune or endocrine dysfunction, autoimmune disorders, reactions to vaccinations, hospitalizations, and malignancy
• Data analysis plan:
  A formal statistical analysis plan (SAP) will include details of all planned analyses and presentation of study data. Since this is an observational study, descriptive analyses will be provided. Descriptive statistics will comprise the number of observations (n), mean, standard deviation (SD), median, minimum, and maximum for continuous variables, and n and percent for categorical variables. Data will be presented for all patients enrolled in the study. An analysis of all study participants combined will be provided. Separate analyses will also be conducted for prospective and retrospective reports.