Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients
- Conditions
- Hepatocellular CarcinomaDifferentiated Thyroid CarcinomaRenal Cell Carcinoma
- Registration Number
- NCT03776123
- Lead Sponsor
- Ipsen
- Brief Summary
The objective of this Post Marketing Surveillance (PMS) is to collect and describe safety and effectiveness profile of Cabometyx™ in real clinical practice setting, according to the approved labelling after the approval of marketing authorization.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 347
- Patients who meet 'Indications' of label for Cabometyx™ as monotherapy
- Patients who are treated with Cabometyx™ for the first time according to label for Cabometyx™ as monotherapy
- Patients who are aged 18 years or older
- Patients who are willing to provide written consent after being informed of this surveillance
- Patients who are contraindicated for Cabometyx™ based on Cabometyx™ label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who had AEs/SAE after Cabometyx™ administration From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyx™ administration From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) Number of AEs/SAEs after Cabometyx™ administration From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
- Secondary Outcome Measures
Name Time Method Progression Free Survival From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) Objective response rate From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Trial Locations
- Locations (47)
Asan Medical Center (Site B)
🇰🇷Seoul, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Kosin University Gospel Hospital (Site B)
🇰🇷Pusan, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
The Catholic University of Korea, Daejeon ST.Mary's Hospital
🇰🇷Daejeon, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
DONG-A University Hospital (Site A)
🇰🇷Busan, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (site A)
🇰🇷Gyeonggi-do, Korea, Republic of
Daejeon Eulji Medical center, Eulji University
🇰🇷Daejeon, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
DONG-A University Hospital (Site B)
🇰🇷Busan, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Pusan, Korea, Republic of
Gangdong Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital (Site B)
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University (Site B)
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Pusan, Korea, Republic of
Pusan National University Hospital (Site A)
🇰🇷Pusan, Korea, Republic of
Inje University Sanggye Paik Hospital (Site A)
🇰🇷Seoul, Korea, Republic of
Asan Medical Center (Site A)
🇰🇷Seoul, Korea, Republic of
Inje University Sanggye Paik Hospital (Site B)
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University (Site A)
🇰🇷Seoul, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Chungbuk, Korea, Republic of
Keimyung University Dongsan Hospital (Site A)
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Hospital (Site B)
🇰🇷Daegu, Korea, Republic of
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (Site B)
🇰🇷Gyeonggi-do, Korea, Republic of
Korea University Anam Hospital (Site A)
🇰🇷Seoul, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Pusan National University Hospital (Site B)
🇰🇷Pusan, Korea, Republic of
Kosin University Gospel Hospital (Site A)
🇰🇷Pusan, Korea, Republic of
Samsung medical center (Site B)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center (Site C)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Centre (Site A)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center (Site D)
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of