A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy With 5 -Year Pediatric Follow-up
Overview
- Phase
- Not Applicable
- Intervention
- Yervoy
- Conditions
- Melanoma
- Sponsor
- Bristol-Myers Squibb
- Locations
- 1
- Primary Endpoint
- Adverse Pregnancy Outcomes
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Women Exposed to Yervoy (ipilimumab) During Pregnancy
Women Exposed to Yervoy (ipilimumab) During Pregnancy and the Children from These Pregnancies
Intervention: Yervoy
Outcomes
Primary Outcomes
Adverse Pregnancy Outcomes
Time Frame: Time of Conception up to Birth
Elective or spontaneous abortion, fetal death/stillbirth, pre-term delivery, ectopic or molar pregnancy
Incidence of chromosomal birth defects in infants born to mothers exposed to Yervoy while pregnant
Time Frame: Birth up to 12 months
Incidence of structural 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