Yervoy Pregnancy Surveillance Study

Bristol-Myers Squibb

Overview

The study is a global safety surveillance study of pregnancy outcomes in women who were exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age

Study Type

OBSERVATIONAL

Conditions

Melanoma

Interventions

YervoyDRUG

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment Exclusion Criteria: * Women whose ipilimumab exposure is outside the window of pregnancy exposure * Pregnancies for which there is only paternal exposure to Yervoy Other protocol defined inclusion/exclusion criteria could apply

Locations (1)

UBC

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant

Time frame: Birth up to 12 months

Incidence of chromosomal birth defects in infants born to mothers exposed to Yervoy while pregnant

Time frame: Birth up to 12 months

Delays in developmental milestones

Time frame: Birth up to 5 Years

Clinical Signs of Immune or Endocrine Dysfunction

Time frame: Birth up to 5 Years

Clinical Signs of Autoimmune Disorders

Time frame: Birth up to 5 Years

Clinical Signs of Serious Infections and Malignancy

Time frame: Birth up to 5 Years

Adverse Pregnancy Outcomes

Elective or spontaneous abortion, fetal death/stillbirth, pre-term delivery, ectopic or molar pregnancy

Time frame: Time of Conception up to Birth

Data from ClinicalTrials.gov

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