Post-Marketing Surveillance of Lenvima in Korean Patients

Differentiated Thyroid Carcinoma (DTC) Clinical Trial

Official title:

Post-Marketing Surveillance of Lenvima in Korean Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764554
• Other study ID #: E7080-M065-502
• Status: Completed
• Start date: November 10, 2016
• Est. completion date: September 29, 2021

Study information

• Verified date: August 2021
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this post-marketing surveillance (PMS) is to observe the safety profile of Lenvima (lenvatinib) in normal clinical practice setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Differentiated Thyroid Carcinoma (DTC)
• Thyroid Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Eisai Trial Site #18	Anyang	Gyeongji-do
Korea, Republic of	Eisai Trial Site #30	Bundang	Gyeongji-do
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	Busan
Korea, Republic of	Eisai Trial Site #36	Daegu
Korea, Republic of	Eisai Trial Site #4	Daegu
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	Goyang	Gyeongji-do
Korea, Republic of	Eisai Trial Site #13	Gwangju
Korea, Republic of	Eisai Trial Site #25	Incheon
Korea, Republic of	Eisai Trial Site #26	Incheon
Korea, Republic of	Eisai Trial Site #32	Incheon
Korea, Republic of	Eisai Trial Site #19	Jeju
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	Seoul
Korea, Republic of	Eisai Trial Site #21	Suwon	Gyeongji-do
Korea, Republic of	Eisai Trial Site #12	Ulsan
Korea, Republic of	Eisai Trial Site #6	Ulsan
Korea, Republic of	Eisai Trial Site #24	Yangsan	Gyeongsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events, Serious Adverse Events, and Adverse Drug Reactions		Up to 1 year