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.
Study Type
OBSERVATIONAL
Enrollment
658
No intervention will be administered.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Site #32
Cheonan, Chungcheongnam-do, South Korea
Site #35
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
...and 32 more locations
Time frame: 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.
Time frame: From first dose of study drug up to 12 months
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.
Time frame: From first dose of study drug up to 12 months