GIOTRIF rPMS in Korean Patients With NSCLC

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1272 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-12-31

Brief Summary

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To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)

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Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GIOTRIF

GIOTRIF 20mg

Intervention Type DRUG

NSCLC with GIOTRIF 20mg

GIOTRIF 40mg

Intervention Type DRUG

NSCLC with GIOTRIF 40mg

GIOTRIF 30mg

Intervention Type DRUG

NSCLC with GIOTRIF 30mg

Interventions

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GIOTRIF 20mg

NSCLC with GIOTRIF 20mg

Intervention Type DRUG

GIOTRIF 40mg

NSCLC with GIOTRIF 40mg

Intervention Type DRUG

GIOTRIF 30mg

NSCLC with GIOTRIF 30mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients who have been started on GIOTRIF® in accordance with the approved label in Korea
2. Age = 19 years at enrolment
3. Patients who have signed on the data release consent form

Exclusion Criteria

1. Known hypersensitivity to afatinib or any of its excipients
2. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
3. Patients for whom GIOTRIF® is contraindicated according to the local label

Minimum Eligible Age

19 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No