Yervoy Pregnancy Surveillance Study
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/21/2018 |
| Start Date: | September 30, 2016 |
| End Date: | August 31, 2024 |
| Contact: | { Recruiting sites have contact information. Please contact the sites { directly. If there is no contact information, please email: |
| Email: | Clinical.Trials@bms.com |
A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy With 5 -Year Pediatric Follow-up
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
exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age
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
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