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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| 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 AEs/SAEs after Cabometyx™ administration | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) | |
| Progression Free Survival | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients administrated Cabometyx™ at the site (Institutions)
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | 15355 | South Korea | |||
| Hallym University Sacred Heart Hospital |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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| Anyang |
| 14068 |
| South Korea |
| DONG-A University Hospital (Site A) | Busan | 49201 | South Korea |
| DONG-A University Hospital (Site B) | Busan | 49201 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
| Keimyung University Dongsan Hospital (Site A) | Daegu | 42601 | South Korea |
| Keimyung University Dongsan Hospital (Site B) | Daegu | 42601 | South Korea |
| The Catholic University of Korea, Daejeon ST.Mary's Hospital | Daejeon | 34943 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Daejeon Eulji Medical center, Eulji University | Daejeon | 35233 | South Korea |
| Konyang University Hospital | Daejeon | 35365 | South Korea |
| The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (site A) | Gyeonggi-do | 11765 | South Korea |
| The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (Site B) | Gyeonggi-do | 11765 | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | 58128 | South Korea |
| Wonkwang University Hospital | Iksan | 54538 | South Korea |
| The Catholic University of Korea, St. Mary's Hospital | Incheon | 21431 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Inje University Busan Paik Hospital | Pusan | 04551 | South Korea |
| Inje University Haeundae Paik Hospital | Pusan | 48108 | South Korea |
| Pusan National University Hospital (Site A) | Pusan | 49241 | South Korea |
| Pusan National University Hospital (Site B) | Pusan | 49241 | South Korea |
| Kosin University Gospel Hospital (Site A) | Pusan | 49267 | South Korea |
| Kosin University Gospel Hospital (Site B) | Pusan | 49267 | South Korea |
| CHA Bundang Medical Center, CHA University | Seongnam | 13496 | South Korea |
| Inje University Sanggye Paik Hospital (Site A) | Seoul | 01757 | South Korea |
| Inje University Sanggye Paik Hospital (Site B) | Seoul | 01757 | South Korea |
| Korea University Anam Hospital (Site A) | Seoul | 02841 | South Korea |
| Korea University Anam Hospital (Site B) | Seoul | 02841 | South Korea |
| Severance Hospital, Yonsei University (Site A) | Seoul | 03722 | South Korea |
| Severance Hospital, Yonsei University (Site B) | Seoul | 03722 | South Korea |
| Hanyang University Seoul Hospital | Seoul | 04763 | South Korea |
| Gangdong Kyung Hee University Hospital | Seoul | 05278 | South Korea |
| Asan Medical Center (Site A) | Seoul | 05505 | South Korea |
| Asan Medical Center (Site B) | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital, Yonsei University Health System | Seoul | 06273 | South Korea |
| Samsung medical center (Site B) | Seoul | 06351 | South Korea |
| Samsung Medical Center (Site C) | Seoul | 06351 | South Korea |
| Samsung Medical Center (Site D) | Seoul | 06351 | South Korea |
| Samsung Medical Centre (Site A) | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| The Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | 07345 | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | 16247 | South Korea |
| Chungbuk National University Hospital | Taebuk | 28644 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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