Post-Marketing Surveillance of Lenvima in Korean Patients
1 other identifier
observational
132
1 country
32
Brief Summary
The purpose of this post-marketing surveillance (PMS) is to observe the safety profile of Lenvima (lenvatinib) in normal clinical practice setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2016
Longer than P75 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedStudy Start
First participant enrolled
November 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2021
CompletedOctober 7, 2021
August 1, 2021
4.9 years
May 4, 2016
October 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events, Serious Adverse Events, and Adverse Drug Reactions
Up to 1 year
Study Arms (1)
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.
Eligibility Criteria
Participants who are prescribed with Lenvatinib per approved prescribing information of lenvatinib in normal clinical practice setting.
You may qualify if:
- Participants with approved indication for lenvatinib in Korea
- Participants who have written consent for use of personal and medical information for the study purpose
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Korea Inc.lead
Study Sites (32)
Eisai Trial Site #18
Anyang, Gyeongji-do, South Korea
Eisai Trial Site #30
Bundang, Gyeongji-do, South Korea
Eisai Trial Site #14
Goyang, Gyeongji-do, South Korea
Eisai Trial Site #27
Goyang, Gyeongji-do, South Korea
Eisai Trial Site #34
Goyang, Gyeongji-do, South Korea
Eisai Trial Site #21
Suwon, Gyeongji-do, South Korea
Eisai Trial Site #24
Yangsan, Gyeongsangnam-do, South Korea
Eisai Trial Site #15
Busan, South Korea
Eisai Trial Site #16
Busan, South Korea
Eisai Trial Site #17
Busan, South Korea
Eisai Trial Site #20
Busan, South Korea
Eisai Trial Site #22
Busan, South Korea
Eisai Trial Site #37
Busan, South Korea
Eisai Trial Site #36
Daegu, South Korea
Eisai Trial Site #4
Daegu, South Korea
Eisai Trial Site #13
Gwangju, South Korea
Eisai Trial Site #25
Incheon, South Korea
Eisai Trial Site #26
Incheon, South Korea
Eisai Trial Site #32
Incheon, South Korea
Eisai Trial Site #19
Jeju City, South Korea
Eisai Trial Site #1
Seoul, South Korea
Eisai Trial Site #23
Seoul, South Korea
Eisai Trial Site #29
Seoul, South Korea
Eisai Trial Site #31
Seoul, South Korea
Eisai Trial Site #33
Seoul, South Korea
Eisai Trial Site #35
Seoul, South Korea
Eisai Trial Site #38
Seoul, South Korea
Eisai Trial Site #39
Seoul, South Korea
Eisai Trial Site #8
Seoul, South Korea
Eisai Trial Site #9
Seoul, South Korea
Eisai Trial Site #12
Ulsan, South Korea
Eisai Trial Site #6
Ulsan, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2016
First Posted
May 6, 2016
Study Start
November 10, 2016
Primary Completion
September 29, 2021
Study Completion
September 29, 2021
Last Updated
October 7, 2021
Record last verified: 2021-08