Post-Marketing Surveillance of Lenvima in Korean Patients

Sponsor

Eisai Korea Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02764554

Collaborator

(none)

132

Enrollment

Locations

58.6

Actual Duration (Months)

4.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Differentiated Thyroid Carcinoma (DTC)

Study Design

Study Type:

Observational

Actual Enrollment :

132 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Post-Marketing Surveillance of Lenvima in Korean Patients

Actual Study Start Date :

Nov 10, 2016

Actual Primary Completion Date :

Sep 29, 2021

Actual Study Completion Date :

Sep 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Events, Serious Adverse Events, and Adverse Drug Reactions [Up to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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

Participants with approved indication for lenvatinib in Korea
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

Contacts and Locations

Locations

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