A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy With 5 -Year Pediatric Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Adverse Pregnancy Outcomes
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment
排除标准
- •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
研究组 & 干预措施
Women Exposed to Yervoy (ipilimumab) During Pregnancy
Women Exposed to Yervoy (ipilimumab) During Pregnancy and the Children from These Pregnancies
干预措施: Yervoy (Drug)
结局指标
主要结局
Adverse Pregnancy Outcomes
时间窗: 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
时间窗: Birth up to 12 months
Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant
时间窗: Birth up to 12 months
Delays in developmental milestones
时间窗: Birth up to 5 Years
Clinical Signs of Immune or Endocrine Dysfunction
时间窗: Birth up to 5 Years
Clinical Signs of Autoimmune Disorders
时间窗: Birth up to 5 Years
Clinical Signs of Serious Infections and Malignancy
时间窗: Birth up to 5 Years
次要结局
未报告次要终点