Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)

Completed

• Conditions: Thyroid Neoplasms
• Interventions: Drug: Lenvatinib

• Registration Number: NCT02430714
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

This study is a post-marketing surveillance of lenvatinib in participants with unresectable thyroid cancer. The objectives of this study are to capture unknown adverse reactions, incidences of adverse drug reaction, efficacy, factors considered to have effect to safety and effectiveness, and incidences of hypertension, hemorrhagic events and thromboembolic event, and liver disorder.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-30
• Study Start: 2015-05-20
• Primary Completion: 2016-11-06
• Study Completion: 2016-11-06
• Status Verified: 2018-07
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 629

Inclusion Criteria

1. All participants with unresectable thyroid cancer and administrated Lenvatinib.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	Lenvatinib	A prospective, centrally registered investigation will be conducted. The new administering participants are to be registered at the time of administration.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)/adverse drug reactions (ADRs)	up to 1 year

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	up to 1 year