A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 255
- 试验地点
- 117
- 主要终点
- Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)
研究概览
简要总结
Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo.
详细描述
This long-term follow up study will enroll subjects who will be transferred from selected interventional, company sponsored trials with radium-223 dichloride (feeder trials).
The primary objectives are to define the long term safety profile of radium-223 dichloride (for up to 7 years after the last dose of radium-223 dichloride); to assess the incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy; to assess the incidence of bone fractures and bone associated events (e.g., osteoporosis); and, in subjects who receive cytotoxic chemotherapy, to assess the incidence of febrile neutropenia and hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was previously enrolled in a selected company sponsored feeder trial, and has received at least 1 dose of radium 223 dichloride or placebo in the feeder trial
排除标准
- •Not applicable to this follow up study
研究组 & 干预措施
Arm 1
The subjects previously enrolled in a selected radium-223 dichloride feeder trial, their treating health care professional, or caregiver will be contacted in 6-month intervals for follow up and query.
干预措施: Data Collection (Other)
结局指标
主要结局
Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)
时间窗: Up to 7 years
Adverse events considered related to radium-223 dichloride or placebo (received in the feeder studies), first arising or worsening on or after the date the participant signed the 16996 informed consent.
Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)
时间窗: Up to 7 years
Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE)
Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events
时间窗: Up to 7 years
Serious adverse events considered related to radium-223 dichloride or placebo (received in the feeder studies), first arising or worsening on or after the date the participant signed the 16996 informed consent.
Number of Participants With Leukemia
时间窗: Up to 7 years
Number of Participants With Myelodysplastic Syndrome
时间窗: Up to 7 years
Number of Participants With Aplastic Anemia
时间窗: Up to 7 years
Number of Participants With Primary Bone Cancer
时间窗: Up to 7 years
Number of Participants With Any Other New Primary Malignancy
时间窗: Up to 7 years
Number of Participants With Bone Fractures
时间窗: Up to 7 years
Number of Participants With Bone-associated Events
时间窗: Up to 7 years
Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy
时间窗: Up to 7 years
Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy
时间窗: Up to 7 years
次要结局
未报告次要终点