Post-Marketing Surveillance of Lenvima in Korean Patients

Completed

• Conditions: Differentiated Thyroid Carcinoma (DTC)

• Registration Number: NCT02764554
• Lead Sponsor: Eisai Korea Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-06
• Study Start: 2016-11-10
• Status Verified: 2021-08
• Primary Completion: 2021-09-29
• Study Completion: 2021-09-29
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Investigators will refer to approved indications and contraindications regarding exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events, Serious Adverse Events, and Adverse Drug Reactions	Up to 1 year

Trial Locations

Locations (32)

Eisai Trial Site #18; 🇰🇷 Anyang, Gyeongji-do, Korea, Republic of

Eisai Trial Site #30; 🇰🇷 Bundang, 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; 🇰🇷 Goyang, Gyeongji-do, Korea, Republic of

Eisai Trial Site #21; 🇰🇷 Suwon, Gyeongji-do, Korea, Republic of

Eisai Trial Site #24; 🇰🇷 Yangsan, Gyeongsangnam-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

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