The purpose of this study is to collect and evaluate the following information in relation to the safety and the efficacy of Lenvatinib in lenvatinib/pembrolizumab combination therapy 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 approved product package insert of lenvatinib in lenvatinib/pembrolizumab combination therapy (3) Known adverse drug reactions (4) Non-serious adverse drug reactions (5) Other safety and efficacy related information.
Study Type
OBSERVATIONAL
Enrollment
135
No intervention will be administered.
Eisai Site #04
Bundang, South Korea
Eisai Site #02
Busan, South Korea
Eisai Site #10
Busan, South Korea
Eisai Site #17
Busan, South Korea
Eisai Site #06
Daegu, South Korea
Eisai Site #03
Ilsan, South Korea
Eisai Site #05
Jeonju, South Korea
Eisai Site #08
Seoul, South Korea
Eisai Site #09
Seoul, South Korea
Eisai Site #11
Seoul, South Korea
...and 9 more locations
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 the first dose of the study drug up to 48 weeks
Number of Participants With Serious Adverse Drug Reactions (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. Adverse events (AEs) with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
Time frame: From the first dose of the study drug up to 48 weeks
Number of Participants With Unexpected AEs
An 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 the first dose of the study drug up to 48 weeks
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 the first dose of the study drug up to 48 weeks
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.
Time frame: From the first dose of the study drug up to 48 weeks
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 the first dose of the study drug up to 48 weeks
Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR) and Stable Disease (SD) [Objective Response Rate (ORR)]
ORR is defined as the percentage of participants with BOR of CR, PR and SD as determined by investigator.
Time frame: From the first dose of the study drug up to 48 weeks
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