Clinical trial NCT02764554: Post-Marketing Surveillance of Lenvima in Korean Patients
Official title: Post-Marketing Surveillance of Lenvima in Korean Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Differentiated Thyroid Carcinoma (DTC)
Keywords: Post-Marketing Surveillance
Lenvima
Lenvatinib
E7080
Differentiated thyroid carcinoma
Refractory to radioactive iodine
Progressive
locally recurrent
metastatic
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-06
Enrollment: 132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are prescribed with Lenvatinib per approved prescribing information of lenvatinib in normal clinical practice setting.

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Adverse Events, Serious Adverse Events, and Adverse Drug Reactions
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Eisai Trial Site #18
state: Gyeongji-do
city: Bundang
country: Korea, Republic of
facility: Eisai Trial Site #30
state: Gyeongji-do
city: Goyang
country: Korea, Republic of
facility: Eisai Trial Site #14
state: Gyeongji-do
city: Goyang
country: Korea, Republic of
facility: Eisai Trial Site #27
state: Gyeongji-do
city: Goyang
country: Korea, Republic of
facility: Eisai Trial Site #34
state: Gyeongji-do
city: Suwon
country: Korea, Republic of
facility: Eisai Trial Site #21
state: Gyeongji-do
city: Yangsan
country: Korea, Republic of
facility: Eisai Trial Site #24
state: Gyeongsangnam-do
city: Busan
country: Korea, Republic of
facility: Eisai Trial Site #15
city: Busan
country: Korea, Republic of
facility: Eisai Trial Site #16
city: Busan
country: Korea, Republic of
facility: Eisai Trial Site #17
city: Busan
country: Korea, Republic of
facility: Eisai Trial Site #20
city: Busan
country: Korea, Republic of
facility: Eisai Trial Site #22
city: Busan
country: Korea, Republic of
facility: Eisai Trial Site #37
city: Daegu
country: Korea, Republic of
facility: Eisai Trial Site #36
city: Daegu
country: Korea, Republic of
facility: Eisai Trial Site #4
city: Gwangju
country: Korea, Republic of
facility: Eisai Trial Site #13
city: Incheon
country: Korea, Republic of
facility: Eisai Trial Site #25
city: Incheon
country: Korea, Republic of
facility: Eisai Trial Site #26
city: Incheon
country: Korea, Republic of
facility: Eisai Trial Site #32
city: Jeju
country: Korea, Republic of
facility: Eisai Trial Site #19
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #1
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #23
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #29
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #31
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #33
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #35
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #38
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #39
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #8
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #9
city: Ulsan
country: Korea, Republic of
facility: Eisai Trial Site #12
city: Ulsan
country: Korea, Republic of
facility: Eisai Trial Site #6
Study officials:
References: