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During the study period, no participants were enrolled in the study despite extensive recruitment methods.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women Exposed to Yervoy (ipilimumab) During Pregnancy | Women Exposed to Yervoy (ipilimumab) During Pregnancy and the Children from These Pregnancies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yervoy | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant | Birth up to 12 months | |
| Incidence of chromosomal birth defects in infants born to mothers exposed to Yervoy while pregnant | Birth up to 12 months | |
| Delays in developmental milestones | Birth up to 5 Years | |
| Clinical Signs of Immune or Endocrine Dysfunction | Birth up to 5 Years | |
| Clinical Signs of Autoimmune Disorders | Birth up to 5 Years | |
| Clinical Signs of Serious Infections and Malignancy | Birth up to 5 Years | |
| Adverse Pregnancy Outcomes | Elective or spontaneous abortion, fetal death/stillbirth, pre-term delivery, ectopic or molar pregnancy | Time of Conception up to Birth |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UBC | Baltimore | Maryland | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |