Post-Marketing Surveillance of Lenvima in Korean Patients

October 6, 2021 updated by: Eisai Korea Inc.
The purpose of this post-marketing surveillance (PMS) is to observe the safety profile of Lenvima (lenvatinib) in normal clinical practice setting.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Eisai Trial Site #15
      • Busan, Korea, Republic of
        • Eisai Trial Site #16
      • Busan, Korea, Republic of
        • Eisai Trial Site #17
      • Busan, Korea, Republic of
        • Eisai Trial Site #20
      • Busan, Korea, Republic of
        • Eisai Trial Site #22
      • Busan, Korea, Republic of
        • Eisai Trial Site #37
      • Daegu, Korea, Republic of
        • Eisai Trial Site #36
      • Daegu, Korea, Republic of
        • Eisai Trial Site #4
      • Gwangju, Korea, Republic of
        • Eisai Trial Site #13
      • Incheon, Korea, Republic of
        • Eisai Trial Site #25
      • Incheon, Korea, Republic of
        • Eisai Trial Site #26
      • Incheon, Korea, Republic of
        • Eisai Trial Site #32
      • Jeju, Korea, Republic of
        • Eisai Trial Site #19
      • Seoul, Korea, Republic of
        • Eisai Trial Site #1
      • Seoul, Korea, Republic of
        • Eisai Trial Site #23
      • Seoul, Korea, Republic of
        • Eisai Trial Site #29
      • Seoul, Korea, Republic of
        • Eisai Trial Site #31
      • Seoul, Korea, Republic of
        • Eisai Trial Site #33
      • Seoul, Korea, Republic of
        • Eisai Trial Site #35
      • Seoul, Korea, Republic of
        • Eisai Trial Site #38
      • Seoul, Korea, Republic of
        • Eisai Trial Site #39
      • Seoul, Korea, Republic of
        • Eisai Trial Site #8
      • Seoul, Korea, Republic of
        • Eisai Trial Site #9
      • Ulsan, Korea, Republic of
        • Eisai Trial Site #12
      • Ulsan, Korea, Republic of
        • Eisai Trial Site #6
    • Gyeongji-do
      • Anyang, Gyeongji-do, Korea, Republic of
        • Eisai Trial Site #18
      • Bundang, Gyeongji-do, Korea, Republic of
        • Eisai Trial Site #30
      • Goyang, Gyeongji-do, Korea, Republic of
        • Eisai Trial Site #14
      • Goyang, Gyeongji-do, Korea, Republic of
        • Eisai Trial Site #27
      • Goyang, Gyeongji-do, Korea, Republic of
        • Eisai Trial Site #34
      • Suwon, Gyeongji-do, Korea, Republic of
        • Eisai Trial Site #21
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, Korea, Republic of
        • Eisai Trial Site #24

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who are prescribed with Lenvatinib per approved prescribing information of lenvatinib in normal clinical practice setting.

Description

Inclusion criteria:

Participants who meet the following criteria will be eligible for inclusion in the study:

  1. Participants with approved indication for lenvatinib in Korea
  2. Participants who have written consent for use of personal and medical information for the study purpose

Exclusion Criteria:

Investigators will refer to approved indications and contraindications regarding exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Lenvatinib 4 milligram (mg) and 10 mg capsule
Participants who are prescribed with Lenvatinib per approved prescribing information of lenvatinib in normal clinical practice setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events, Serious Adverse Events, and Adverse Drug Reactions
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Korea Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2016

Primary Completion (Actual)

September 29, 2021

Study Completion (Actual)

September 29, 2021

Study Registration Dates

First Submitted

May 4, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 7, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7080-M065-502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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