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The purpose of this study is to describe the following safety and the efficacy of Lenvima for the first-line treatment indication of participants with uHHC in the post marketing setting: (1) Serious adverse events and serious adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in the precautions for use (3) Known adverse drug reactions (4) Non-serious adverse drug reactions (5) Other safety and efficacy related information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Participants with uHCC who are prescribed with Lenvima within the scope of the approved label for Korea under the medical judgment of the investigator will be enrolled and observed for up to 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | No intervention will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | A SAE is defined as any untoward medical occurrence: resulting in death; life threatening requiring hospitalization or prolongation of hospitalization; resulting in persistent or significant disability or incapacity; resulting in birth defect or congenital anomaly or medically important due to other reasons than above mentioned criteria. | From first dose of study drug up to 12 months |
| Number of Participants With Serious Adverse Drug Reactions (ADRs) | Serious ADR is defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition. | From first dose of study drug up to 12 months |
| Number of Participants With Unexpected AEs | AE is defined as any untoward and unintended signs (example, anomalies in laboratory test results) or symptoms/diseases occurring during administration/use of drugs, etc., which do not necessarily have a causal relationship with the drug in question. | From first dose of study drug up to 12 months |
| Number of Participants With Unexpected ADRs | An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. | From first dose of study drug up to 12 months |
| Number of Participants With Known ADRs | An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Response | Overall response will include complete response (CR), and partial response (PR). The confirmation of overall response will be based on investigator's judgement. | From first dose of study drug up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with uHHC administered with Lenvima within the scope of the approved label for Korea under the medical judgment of the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #32 | Cheonan | Chungcheongnam-do | South Korea | |||
| Site #35 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39320906 | Derived | Kang W, Kim YJ, Kim SU, Seo YS, Kim JW, Kim JH, Park SY, Baek YH, Kim KM, Lee HL, Yoon KT, Kim H, Cheong JY, Hwang JS, Kim JH, Kim KM, Sung PS, Kim J, Kim DY. Real-world safety and effectiveness of lenvatinib in unresectable hepatocellular carcinoma in Korea: post-marketing study. Future Oncol. 2024;20(37):2949-2959. doi: 10.1080/14796694.2024.2397328. Epub 2024 Sep 25. |
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Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| From first dose of study drug up to 12 months |
| Number of Participants With Non-serious ADRs | An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. | From first dose of study drug up to 12 months |
| Bucheon-si |
| Gyeonggi-do |
| South Korea |
| Site #38 | Bucheon-si | Gyeonggi-do | South Korea |
| Site #06 | Goyang-si | Gyeonggi-do | South Korea |
| Site #03 | Seongnam-si | Gyeonggi-do | South Korea |
| Site #13 | Suwon | Gyeonggi-do | South Korea |
| Site #27 | Suwon | Gyeonggi-do | South Korea |
| Site #15 | Uijeongbu-si | Gyeonggi-do | South Korea |
| Site #37 | Changwon | Gyeongsangnam-do | South Korea |
| Site #28 | Yangsan | Gyeongsangnam-do | South Korea |
| Site #29 | Yangsan | Gyeongsangnam-do | South Korea |
| Site #31 | Busan | South Korea |
| Site #39 | Busan | South Korea |
| Site #40 | Busan | South Korea |
| Site #17 | Daegu | South Korea |
| Site #18 | Daegu | South Korea |
| Site #26 | Daegu | South Korea |
| Site #30 | Daegu | South Korea |
| Site #41 | Daegu | South Korea |
| Site #19 | Daejeon | South Korea |
| Site #20 | Daejeon | South Korea |
| Site #24 | Daejeon | South Korea |
| Site #34 | Daejeon | South Korea |
| Site #21 | Incheon | South Korea |
| Site #33 | Incheon | South Korea |
| Site #36 | Incheon | South Korea |
| Site #01 | Seoul | South Korea |
| Site #02 | Seoul | South Korea |
| Site #04 | Seoul | South Korea |
| Site #07 | Seoul | South Korea |
| Site #08 | Seoul | South Korea |
| Site #09 | Seoul | South Korea |
| Site #10 | Seoul | South Korea |
| Site #12 | Seoul | South Korea |
| Site #16 | Seoul | South Korea |
| Site #22 | Seoul | South Korea |
| Site #23 | Seoul | South Korea |
| Site #25 | Seoul | South Korea |
| Site #42 | Seoul | South Korea |
| Site #43 | Seoul | South Korea |
| Site #44 | Seoul | South Korea |
| Site #11 | Ulsan | South Korea |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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