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Long-term Observation PMS for Afatinib

NCT02131259 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1605

Last updated 2018-09-07

Study results available
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Summary

In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Afatinib dimaleate

20mg - 50mg

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-07
Primary Completion
2016-12-28
Completion
2016-12-28

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02131259 on ClinicalTrials.gov