Company Name | Bayer Taiwan Co., Ltd. |
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Protocol Number | 21124 |
Title of Study | RAPIT/ Safety and Effectiveness of Xofigo® (Radium-223 dichloride) in Routine Clinical Practice Settings in Taiwan) |
Primary Objective | To describe the safety profiles and the effectiveness of Radium-223 in CRPC patients with symptomatic bone metastases under routine clinical practice in Taiwan. The objective of the extended follow-up period (up to 2 years after the first injection of Radium-223) is to describe the long term safety information (i.e. hematological AEs, events of bone fracture or osteoporosis), and survival in CRPC patients post-treatment of Radium-223 under real-world practice in Taiwan. |
Number of Sites | 10 |
Period of Study | From:2020 Q3 to:2023 Q4 |
Number of Patients | 300人 |
IRB Approval Date | NTUH 2020/03/17 TPVGH 2020/05/01 CGMHLK 2020/04/29 KFSYSCC In Process TSGH 2020/04/18 CMUH 2020/05/07 TCVGH 2020/05/25 CYCH 2020/05/20 KMUH 2020/05/07 CHIMEI In Process |
Publication Plan / Date | 2024 Q1 |